Massager, Powered Inflatable Tube
FDA product code IRP · Class II (moderate risk) · 21 CFR 890.5650 · Physical Medicine
156510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Daesung Maref Co., Ltd. 8
- Xiamen Weiyou Intelligent Technology Co., Ltd. 7
- NormaTec Industries, LP 7
- Mego Afek AC , Ltd. 6
- Wonjin Mulsan Co., Ltd. 5
- Chengdu Cryo-Push Medical Technology Co.,Ltd 4
- Zenith Technical Innovations 4
- Progressive Medical Technology, Inc. 3
- Bio Compression Systems, Inc. 3
- Xiamen Senyang Co., Ltd. 3
- Maxstar Industrial Co., Ltd. 3
- Jkh Health Co., Ltd. 3
- Rapid Reboot Recovery Products, LLC 2
- Portable Therapeutix 2
- Electro-Biology, Inc. 2
- Manamed, Inc. 2
- Foshan Hongfeng Co., Ltd. 2
- Shenzhen Dongjilian Electronics Co., Ltd. 2
- Won Industrial Co. 2
- Cool Systems, Inc. (Dba Game Ready) 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260944 | ManaCold Compression SystemIRP · Traditional | Manamed, LLC | 08/12/2026SE |
| K260529 | Air Compression Massager (HY-1165)IRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 07/27/2026SE |
| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
| K253919 | Cryo And Thermo Therapy SystemIRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/10/2026SE |
| K252396 | Cryo Sport 2.0 (AVA 501)IRP · Traditional | Avanutri Equipamentos DE Saúde | 05/29/2026SE |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…IRP · Traditional | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 05/05/2026SE |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 04/30/2026SE |
| K252386 | Hot and Cold Compression System (A02-C-032)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/03/2026SE |
| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…IRP · Traditional | Shenzhen Future Electronic Co., Ltd. | 11/13/2025SE |
| K251531 | Air Compression Boots 1018195,1018196IRP · Traditional | Merchsource, LLC | 10/30/2025SE |
| K253150 | Cryon-X Cold CompressionIRP · Special | Jkh Health Co., Ltd. | 10/24/2025SE |
| K251905 | Normatec Elite HipIRP · Traditional | NormaTec Industries, LP | 09/18/2025SE |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)IRP · Traditional | Shenzhen Yicai Health Technology Co., Ltd. | 09/17/2025SE |
| K250244 | Compression Therapy Device (LGT-2210DS)IRP · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 07/25/2025SE |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression…IRP · Traditional | Xiamen Taotao Technology Co., Ltd. | 07/23/2025SE |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)IRP · Traditional | Zamar Medical D.O.O. | 05/05/2025SE |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)IRP · Traditional | Shenzhen Urion Technology Co., Ltd. | 04/25/2025SE |
| K242140 | Air Compression Leg Massager (K-705)IRP · Traditional | Jiale Health Technology Shenzhen Co., Ltd. | 03/17/2025SE |
| K243206 | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…IRP · Traditional | Sichuan Qianli-Beoka Medical Technology, Inc. | 02/19/2025SE |
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg…IRP · Special | Avanos Medical, Inc. | 01/31/2025SE |
| K243791 | Air Pressure Therapy SystemIRP · Special | Xiamen Weiyou Intelligent Technology Co., Ltd. | 01/13/2025SE |
| K243177 | Sacs ProIRP · Traditional | Elastimed , Ltd. | 12/23/2024SE |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H)IRP · Traditional | Shenzhen Ruiyi Business Technology Co., Ltd. | 11/20/2024SE |
| K243320 | Air Pressure Therapy System (VU-IPC04B)IRP · Special | Xiamen Weiyou Intelligent Technology Co., Ltd. | 11/18/2024SE |
| K242940 | Xrecovery (XR-001)IRP · Traditional | Shenzhen Xinrun Electric Appliances Co, Ltd. | 11/14/2024SE |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)IRP · Traditional | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | 10/08/2024SE |
| K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522)IRP · Traditional | Zhangzhou Easepal Medical Science and Technology… | 09/17/2024SE |
| K241256 | JetBoots PRO PlusIRP · Traditional | Therabody, Inc. | 08/30/2024SE |
| K240981 | Air compression leg massagerIRP · Traditional | Huizhou Xinyi Technology Co., Ltd. | 08/02/2024SE |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M)IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/14/2024SE |
| K240986 | Cold CompressionIRP · Special | Jkh Health Co., Ltd. | 05/01/2024SE |
| K240122 | Normatec EliteIRP · Traditional | NormaTec Industries, LP | 03/21/2024SE |
| K230524 | Cold Compression Wrap ProIRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 01/19/2024SE |
| K223729 | FLOWpressoIRP · Traditional | Medella Health Limited | 12/21/2023SE |
| K233536 | Air Compression Recovery SystemIRP · Traditional | Shenzhen Dongjilian Medical Tech Co., Ltd. | 12/16/2023SE |
| K223541 | Cold/Hot CompressionIRP · Traditional | Jkh Health Co., Ltd. | 10/27/2023SE |
| K230500 | Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801…IRP · Traditional | Jiangsu Maxf Electric Appliance Co., Ltd. | 10/26/2023SE |
| K231912 | Therm-XIRP · Special | Zenith Technical Innovations | 07/27/2023SE |
| K231437 | LF900IRP · Special | Daesung Maref Co., Ltd. | 07/19/2023SE |
| K230385 | Ballancer Platinum (1222)IRP · Traditional | Mego Afek | 04/04/2023SE |
| K222991 | Air Compression Leg Massager (model: EMK-701)IRP · Traditional | Xiamen Emoka Health Science & Technology Co., Ltd. | 03/15/2023SE |
| K223464 | Leg and Foot Air Wave Pressure Therapy DeviceIRP · Traditional | Zhangzhou Easepal Innovation CO , Ltd. | 03/14/2023SE |
| K222136 | Cryo-Thermo Compression Device (FGK002)IRP · Traditional | Suzhou Microport Rehabtech (Group) Co., Ltd. | 03/08/2023SE |
| K222924 | Leg Massager RF-ALM070IRP · Traditional | Shenzhen Ruiyi Business Technology Co., Ltd. | 12/23/2022SE |
| K222949 | Air Compression Leg Massager (Model: LY-670D)IRP · Traditional | Zhejiang Luyao Electronics Technology Co., Ltd. | 12/22/2022SE |
| K221862 | YY-A02-B Overlapped Compression TherapyIRP · Traditional | Huizhou Xinyi Technology Co., Ltd. | 12/08/2022SE |
| K222669 | Cryopush Cold Compression DeviceIRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 12/05/2022SE |
| K223164 | Aquilo Sports CCT1500 SystemIRP · Traditional | Aquilo Sports, LLC | 11/04/2022SE |
| K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)IRP · Traditional | Shenzhen Dongjilian Medical Tech Co., Ltd. | 09/30/2022SE |
| K201730 | Powered Inflatable Tube Massager - SLIM UP DRAINIRP · Traditional | Foggiare Technologies, LLC | 08/22/2022SE |
| K221666 | Normatec GoIRP · Traditional | NormaTec Industries, LP | 07/14/2022SE |
| K213745 | Air Compression Therapy Device, model: ST-502IRP · Traditional | Shenzhen Future Electronic Co., Ltd. | 03/31/2022SE |
| K211850 | Air Compression Leg Massager (model: FE-7204B)IRP · Traditional | Xiamen Healthpal Electronic Co.,Ltd | 03/03/2022SE |
| K220217 | Normatec 3IRP · Traditional | NormaTec Industries, LP | 02/25/2022SE |
| K212935 | Air Pressure Foot MassagerIRP · Traditional | Xiamen Simo Electronic Co., Ltd. | 02/19/2022SE |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…IRP · Traditional | Bio Compression Systems, Inc. | 02/16/2022SE |
| K212713 | Air compression leg massager HY-1117AIRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 01/18/2022SE |
| K212169 | Air compression therapy system FO3002IRP · Traditional | Foshan Hongfeng Co., Ltd. | 11/23/2021SE |
| K213000 | Air Compression Massager (Model LF-FT003)IRP · Traditional | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 11/15/2021SE |
| K211745 | RecoveryAir PROIRP · Traditional | Theragun, Inc. | 10/04/2021SE |
| K211283 | Compressible Limb and Circulation Therapy System, Model POWER-Q2300IRP · Traditional | Wonjin Mulsan Co., Ltd. | 09/14/2021SE |
| K212491 | Air Relax Pro Model AR-4.0IRP · Traditional | Diode Art Engineering Doing Business AS Air Relax | 09/02/2021SE |
| K202395 | SP-1000, SP-2000IRP · Traditional | Daesung Maref Co., Ltd. | 09/01/2021SE |
| K210913 | V12 ProIRP · Traditional | Slk Medical GmbH | 08/04/2021SE |
| K203498 | LX9maxIRP · Traditional | Daesung Maref Co., Ltd. | 07/02/2021SE |
| K203019 | LF900IRP · Traditional | Daesung Maref Co., Ltd. | 06/22/2021SE |
| K201935 | Air Pressure Therapy SystemIRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/22/2021SE |
| K210281 | Fist Assist Devices Model FA-1IRP · Traditional | Fist Assist Devices, LLC | 06/17/2021SE |
| K211460 | Air Relax Plus Model AR-3.0IRP · Traditional | Diode Art Engineering Doing Business AS Air Relax | 05/25/2021SE |
| K210967 | Air Pressure Therapy System: VU-IPC06IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 05/11/2021SE |
| K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008IRP · Traditional | Foshan Hongfeng Co., Ltd. | 03/25/2021SE |
| K200660 | Compressible Limb and Circulation Therapy SystemIRP · Traditional | Wonjin Mulsan Co., Ltd. | 03/08/2021SE |
| K202693 | NeoWave Pain Relief and Recovery System, Model# T16-2020IRP · Traditional | Eva Medtec, Inc. | 03/05/2021SE |
| K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)IRP · Traditional | Maxstar Industrial Co., Ltd. | 03/05/2021SE |
| K210240 | Air Compression Therapy Device, model HW6007IRP · Traditional | Konliking Tech & Dev. Limited | 02/22/2021SE |
| K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE SystemsIRP · Traditional | Mks Paris | 01/11/2021SE |
| K203552 | Rapid RebootIRP · Traditional | Rapid Reboot Recovery Products, LLC | 12/22/2020SE |
| K201694 | Air Compression Therapy DeviceIRP · Traditional | Shenzhen Dongjilian Electronics Co., Ltd. | 11/19/2020SE |
| K202044 | Powerpress Recovery UnitIRP · Traditional | Hanuri Distribution, Inc. | 10/21/2020SE |
| K201645 | Massage Compression BootsIRP · Traditional | Jkh USA, LLC | 09/15/2020SE |
| K200351 | PlasmaFlightIRP · Traditional | Manamed, Inc. | 08/05/2020SE |
| K192466 | Air Compression Therapy SystemIRP · Traditional | Shenzhen Lifotronic Technology Co., Ltd. | 06/22/2020SE |
| K193354 | Air Compression Therapy DeviceIRP · Traditional | Shenzhen Dongjilian Electronics Co., Ltd. | 06/08/2020SE |
| K192358 | Pressure Therapy System PT1003IRP · Traditional | Xiamen Senyang Co., Ltd. | 04/23/2020SE |
| K193550 | Therm-XIRP · Traditional | Zenith Technical Innovations | 02/28/2020SE |
| K192607 | LiteWalkIRP · Traditional | Viasonix , Ltd. | 12/19/2019SE |
| K192114 | Game Ready GRPro 2.1 SystemIRP · Traditional | Cool Systems, Inc. (Dba Game Ready) | 10/29/2019SE |
| K191862 | Compression Therapy Device Model LGT-2200SPIRP · Traditional | Guangzhou Longest Science & Technology Co., Ltd. | 10/29/2019SE |
| K192252 | ProPerformance Recovery SystemIRP · Traditional | Menlo Brands, LLC | 09/19/2019SE |
| K173158 | Air RelaxIRP · Special | Maxstar Industrial Co., Ltd. | 05/30/2019SE |
| K190493 | Recovery Pump, 737R (RPX)IRP · Traditional | Mego Afek AC , Ltd. | 05/15/2019SE |
| K190854 | Therm-XIRP · Abbreviated | Zenith Technical Innovations | 05/10/2019SE |
| K190015 | Ballancer Gold, 1212IRP · Traditional | Mego Afek AC , Ltd. | 03/25/2019SE |
| K183702 | Polar Care WaveIRP · Traditional | Breg, Inc. | 03/01/2019SE |
| K181409 | Pressure Therapy System PT1003IRP · Traditional | Xiamen Senyang Co., Ltd. | 02/19/2019SE |
| K183169 | Pulse 2.0, Pulse Pro 2.0IRP · Traditional | NormaTec Industries, LP | 12/27/2018SE |
| K182668 | Rapid Reboot Compression Therapy SystemIRP · Traditional | Rapid Reboot Recovery Products, LLC | 12/14/2018SE |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro AthleteIRP · Traditional | Zenith Technical Innovations | 08/03/2018SE |
| K171685 | Med4 EliteIRP · Traditional | Cool Systems, Inc. (Dba Game Ready) | 09/29/2017SE |
| K161907 | Pressure Therapy SystemIRP · Traditional | Xiamen Senyang Co., Ltd. | 02/23/2017SE |
| K163280 | RP Lite 760RIRP · Special | Mego Afek AC , Ltd. | 01/27/2017SE |
| K160178 | Lympha-Flow(LF1200)IRP · Special | Daesung Maref Co., Ltd. | 01/11/2017SE |
| K160608 | NormaTec Pulse and NormaTec Pulse ProIRP · Traditional | NormaTec Industries, LP | 04/13/2016SE |
| K150269 | Ballancer 505 System, Model 1201-ACIRP · Traditional | Mego Afek AC , Ltd. | 05/26/2015SE |
| K150033 | Air Compressible Limb Therapy SystemIRP · Special | Daesung Maref Co., Ltd. | 04/20/2015SE |
| K143197 | Nice1IRP · Traditional | Nice Recovery Systems, LLC | 12/23/2014SE |
| K140519 | Recovery Pump 737RIRP · Traditional | Mego Afek AC , Ltd. | 06/16/2014SE |
| K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for OTC UseIRP · Traditional | Portable Therapeutix | 03/11/2014SE |
| K130385 | Compressible Limb Sleeve SystemIRP · Traditional | Maxstar Industrial Co., Ltd. | 02/18/2014SE |
| K122112 | 2004-OC Massage System, 2008-OC Massage SystemIRP · Traditional | Bio Compression Systems, Inc. | 04/09/2013SE |
| K123829 | Portable Therapeutix Squid Active Cold Compression Device and Cold PackIRP · Traditional | Portable Therapeutix, LLC | 04/03/2013SE |
| K122154 | Powerplay Muscle MassagerIRP · Traditional | Fig, LLC | 11/21/2012SE |
| K120166 | Compressible Limb and Circulation Therapy SystemIRP · Traditional | Won Industrial Co. | 05/14/2012SE |
| K113275 | Compressible Limb Therapy SystemIRP · Traditional | Wonjin Mulsan Co., Ltd. | 02/27/2012SE |
| K112441 | Compressible Limb and Circulation Therapy SystemIRP · Traditional | Daesung Maref Co., Ltd. | 01/17/2012SE |
| K112890 | Normatec MVPIRP · Traditional | NormaTec Industries, LP | 01/04/2012SE |
| K112479 | DSJ MassagerIRP · Traditional | Mego Afek AC , Ltd. | 12/07/2011SE |
| K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7)IRP · Traditional | Daesung Maref Co., Ltd. | 03/04/2011SE |
| K102319 | Compressible Limb and Circulation Therapy System Model WIC-2008IRP · Traditional | Won Industrial Co. | 01/28/2011SE |
| K100656 | Compressible Limb Therapy System Model WHF-324 (POWER-Q1000 Plus)IRP · Special | Wonjin Mulsan Co., Ltd. | 05/26/2010SE |
| K092435 | Verseo Air Pressure MassagerIRP · Traditional | The American Export Group & International Services | 03/09/2010SE |
| K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (POWER-Q1000)IRP · Traditional | Wonjin Mulsan Co., Ltd. | 01/23/2009SE |
| K071596 | Potable Air Massager Putifino, Model AM-7IRP · Traditional | Nihon Seimitsu Sokki Co., Ltd. | 02/15/2008SE |
| K072620 | Game Ready Classic System, Model 550550IRP · Traditional | Coolsystems, Inc. | 10/31/2007SE |
| K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed…IRP · Traditional | Coolsystems, Inc. | 06/29/2007SE |
| K040905 | Wellness/JoliveteIRP · Traditional | Tohkai Precision Ind. , Ltd. | 02/23/2005SE |
| K032505 | Air Press MassagerIRP · Traditional | Telebrands Corp | 09/24/2003SE |
| K030437 | Relaxor Perfect Touch Air Massaging SystemIRP · Traditional | Salton, Inc. | 04/10/2003SE |
| K013061 | Biotouch Massage Therapy SystemIRP · Traditional | Tactile Systems Technology, Inc. | 07/01/2002SE |
| K003909 | Proact 1IRP · Traditional | Proact Co. | 06/13/2001SE |
| K000655 | Ppcid- Pneumatic Peripheral Circulation Improvement (Footrest) DeviceIRP · Traditional | Ahava Stein | 03/26/2001SE |
| K994057 | Slendair 4000 Compression SystemIRP · Traditional | Medical Compression Systems (Dbn) , Ltd. | 03/03/2000SE |
| K991921 | Intermittent Compression Boot for OTCIRP · Traditional | Eischoco, Inc. | 08/13/1999SE |
| K974395 | Atlant'sIRP · Traditional | Grad-Line Corp. | 10/22/1998SE |
| K964957 | Intermittent Compressor SystemIRP · Traditional | Eischoco, Inc. | 02/24/1997SE |
| K961426 | Bio BoostIRP · Traditional | Bio Compression Systems, Inc. | 10/28/1996SE |
| K953516 | Medcomp MC 5 Gradient Sequential PumpIRP · Traditional | Yoav Gershoni | 12/08/1995SN |
| K951769 | CryopressIRP · Traditional | Grimm Scientific Industries, Inc. | 10/16/1995SE |
| K915638 | Talley TM200 Intermttent Compression UnitIRP · Traditional | Progressive Medical Technology, Inc. | 02/11/1992SE |
| K915637 | Talley TM500 Sequential Multicom Compression Syst.IRP · Traditional | Progressive Medical Technology, Inc. | 02/11/1992SE |
| K915092 | Talley TM300 Sequential Multicom Compression SystIRP · Traditional | Progressive Medical Technology, Inc. | 02/11/1992SE |
| K914774 | Multipulse Sequential Compression UnitIRP · Traditional | Talley Group, Ltd. | 02/11/1992SE |
| K914142 | Hemo-Pulse 2000IRP · Traditional | Chrono Dynamics, Ltd. | 01/03/1992SE |
| K912004 | Shepard Cryopress/Camp Multi-Temp Sport PumpsIRP · Traditional | Shepherd Medical Products, Inc. | 07/25/1991SE |
| K901022 | Powered Inflatable Tube Massager, Sport-MedIRP · Traditional | Damor America, Inc. | 03/14/1990SE |
| K893950 | Ventipress 24 and 14 Pressure VentilatorIRP · Traditional | Ventipress OY | 08/03/1989SE |
| K874688 | Flowtron AC200/2IRP · Traditional | Huntleigh Technology, Inc. | 09/23/1988SE |
| K860632 | Ebi Hand Massaging Pump (HMP)IRP · Traditional | Electro-Biology, Inc. | 04/18/1986SE |
| K852264 | Ebi Foot Massaging PumpIRP · Traditional | Electro-Biology, Inc. | 07/19/1985SE |
| K834507 | Hydropulse(Grossan);Inflat Tube MassIRP · Traditional | Amrex-Zetron, Inc. | 01/17/1984SE |
| K832920 | Intermittent Compression PumpsIRP · Traditional | Chattanooga Group, Inc. | 11/07/1983SE |
| K821920 | I.C.E. BoxIRP · Traditional | Lhs Industries | 08/31/1982SE |
| K781964 | Compression Devices, LimbIRP · Traditional | Alba-Waldensian, Inc. | 12/12/1978SE |
| K780710 | Air Massage SystemIRP · Traditional | Theracom C/O Arent, Fox, Kintner, Plotki | 05/09/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2463-2025 Class II | Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number:…Regulatory documentation error and misleading color packaging claim. | Zhejiang Luyao Electronics Technology Co.… | 01/17/2025Open, Classified |
| Z-1398-2023 Class II | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to…Error in the Introduction section of the user manual that indicates the device may be used for the… | Compass Health Brands (Corporate Office) | 03/07/2023Open, Classified |
| Z-0205-2018 Class II | Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection…Distribution of unapproved devices with incorrect air compression level setup | Won Industry Co. | 01/13/2017Terminated |
| Z-0204-2018 Class II | Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for…Distribution of unapproved devices with incorrect air compression level setup | Won Industry Co. | 01/13/2017Terminated |
| Z-3210-2011 | Game Ready Professional Therapy System, a cryotherapy device. Intended to treat…It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined… | CoolSystems, Inc. | 08/23/2011Terminated |