Lift, Patient, Non-Ac-Powered
FDA product code FSA · Class I (low risk) · 21 CFR 880.5510 · General Hospital
13510(k) clearances
0PMA approvals
127recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942807 | Surgical Lift SheetFSA · Traditional | Surgin Surgical Instrumentation, Inc. | 08/02/1994SE |
| K930625 | Sanitas Patient LiftFSA · Traditional | Dutton-Lainson Co. | 09/13/1993SE |
| K902141 | Anolift - Portable & Anolift - GantryFSA · Traditional | Anodyne Corp. | 09/12/1990SE |
| K860837 | Hoyer One-Touch Power LifterFSA · Traditional | Ted Hoyer & Co., Inc. | 03/27/1986SE |
| K851844 | MoliftFSA · Traditional | Madshus A/S | 05/17/1985SE |
| K844976 | Medi-Man Water Powered Bath Lift & Hydraulic LiftFSA · Traditional | Medi-Man Rehabilitation Products, Inc. | 04/01/1985SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | Setma, Inc. | 05/07/1984SE |
| K841395 | Shower TrolleyFSA · Traditional | Setma, Inc. | 05/07/1984SE |
| K840997 | Battery Powered Patient LiftFSA · Traditional | Invacare Corp. | 04/17/1984SE |
| K823206 | Martin Pelvic LiftFSA · Traditional | Martin Pelvic Lift Co. | 04/28/1983SE |
| K811899 | Century Lift Transfer SystemFSA · Traditional | Century Manufacturing Co. | 07/23/1981SE |
| K792601 | Lifelift Models One and TwoFSA · Traditional | Corda Int'L Holiday, Inc. | 12/31/1979SE |
| K780684 | Patient LiftFSA · Traditional | Orthopedic Equipment Co., Inc. | 06/06/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1811-2026 Class II | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USAn internal component of the actuators in a certain production batch may not meet the required mechanical… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 03/10/2026Open, Classified |
| Z-1139-2026 Class II | Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training…Potential for fraying on the body support strap. | Community Products, LLC | 12/18/2025Open, Classified |
| Z-1138-2026 Class II | Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift…Potential for fraying on the body support strap. | Community Products, LLC | 12/18/2025Open, Classified |
| Z-1137-2026 Class II | Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device…Potential for fraying on the body support strap. | Community Products, LLC | 12/18/2025Open, Classified |
| Z-1311-2026 Class II | Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists)…A customer experienced that during assembly and load testing of the device, the bolt for mounting the… | Etac A/S | 11/17/2025Open, Classified |
| Z-1310-2026 Class II | Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists)…A customer experienced that during assembly and load testing of the device, the bolt for mounting the… | Etac A/S | 11/17/2025Open, Classified |
| Z-1309-2026 Class II | Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2)…A customer experienced that during assembly and load testing of the device, the bolt for mounting the… | Etac A/S | 11/17/2025Open, Classified |
| Z-1308-2026 Class II | Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2)…A customer experienced that during assembly and load testing of the device, the bolt for mounting the… | Etac A/S | 11/17/2025Open, Classified |
| Z-2032-2025 Class I | Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits…The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on… | Baxter Healthcare Corporation | 05/30/2025Open, Classified |
| Z-2031-2025 Class I | Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile…The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on… | Baxter Healthcare Corporation | 05/30/2025Open, Classified |
| Z-1486-2024 Class II | Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger…Patient lift hanger bar may come loose, which could potentially pose risks to patients. | Human Care Hc Sweden Ab | 02/23/2024Open, Classified |
| Z-1629-2023 Class II | Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in…Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach. | Arjohuntleigh Magog, Inc. | 02/17/2023Open, Classified |
| Z-1205-2023 Class II | Sit to Stand STS500 Patient LiftRisk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to… | Med-Mizer, Inc. | 02/03/2023Open, Classified |
| Z-1204-2023 Class II | Med-Riser MR600 Patient LiftRisk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to… | Med-Mizer, Inc. | 02/03/2023Open, Classified |
| Z-1098-2022 Class I | Sara Plus Active Floor LiftThe device may emit smoke or ignite. | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 04/05/2022Terminated |
| Z-0829-2022 Class II | Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko…An incorrect center bolt was used in the assembly of the product which could result in a patient fall during… | Baxter Healthcare Corporation | 02/21/2022Open, Classified |
| Z-0783-2022 Class II | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift…Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate… | Hill-Rom, Inc. | 01/14/2022Terminated |
| Z-0640-2022 Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Hill-Rom, Inc. | 12/23/2021Open, Classified |
| Z-0639-2022 Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Hill-Rom, Inc. | 12/23/2021Open, Classified |
| Z-0852-2022 Class II | Hanger-Bar 2P 45cmThe Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a… | Human Care USA, Inc. | 11/01/2021Open, Classified |
| Z-0851-2022 Class II | Hanger-Bar 2P 45cmThe Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a… | Human Care USA, Inc. | 11/01/2021Open, Classified |
| Z-2601-2021 Class II | LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number:…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | Hill-Rom, Inc. | 08/11/2021Open, Classified |
| Z-2600-2021 Class II | LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | Hill-Rom, Inc. | 08/11/2021Open, Classified |
| Z-2599-2021 Class II | Stretch Leveller Model Number: 3156200 - The combination of this products allows the…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | Hill-Rom, Inc. | 08/11/2021Open, Classified |
| Z-2598-2021 Class II | FlexoStretch Model Number: 3156057 - The combination of this products allows the user to…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | Hill-Rom, Inc. | 08/11/2021Open, Classified |
| Z-2597-2021 Class II | OctoStretch with Stretch Leveller - The combination of this products allows the user to…Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position… | Hill-Rom, Inc. | 08/11/2021Open, Classified |
| Z-2470-2021 Class II | Arjo Disposable Repositioning Sling, Model AHD001Sling loop straps on device pose a trip hazard. | Getinge Dominican Republic SA | 07/30/2021Terminated |
| Z-2479-2021 Class II | Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring…The spreader bar can disconnect from the scale bottom attachment. | Arjohuntleigh Magog, Inc. | 03/04/2021Terminated |
| Z-0925-2021 Class I | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the…Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the… | Hill-Rom, Inc. | 12/18/2020Terminated |
| Z-1100-2021 Class II | Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with…Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS) | Arjohuntleigh Magog, Inc. | 10/06/2020Terminated |
| Z-0096-2021 Class II | SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE…Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component. | Handicare AB | 08/21/2020Terminated |
| Z-1452-2020 Class II | Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083)…The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 08/22/2019Terminated |
| Z-0166-2020 Class II | Rifton E-Pacer, SKU K660, powered lift deviceA design change to the load-bearing quick release buckle renders the springs in the latch mechanism… | Community Products, LLC | 03/21/2019Terminated |
| Z-0165-2020 Class II | Rifton TRAM Low Base, SKU K320, powered lift deviceA design change to the load-bearing quick release buckle renders the springs in the latch mechanism… | Community Products, LLC | 03/21/2019Terminated |
| Z-0164-2020 Class II | Rifton TRAM Standard Base, SKU K310, powered lift deviceA design change to the load-bearing quick release buckle renders the springs in the latch mechanism… | Community Products, LLC | 03/21/2019Terminated |
| Z-1352-2019 Class II | Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001…The firm has received 7 reports of malfunction for the device in which the hooks have broken off… | Moller Vital | 02/04/2019Open, Classified |
| Z-1351-2019 Class II | Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017…The firm has received 7 reports of malfunction for the device in which the hooks have broken off… | Moller Vital | 02/04/2019Open, Classified |
| Z-0549-2019 Class II | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended…Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster… | Invacare Corporation | 11/16/2018Terminated |
| Z-0589-2019 Class II | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive…Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 10/22/2018Terminated |
| Z-0105-2019 Class II | Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer…The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is… | Liko AB | 07/17/2018Terminated |
| Z-1420-2018 Class II | Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG…Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the… | Autochair | 03/07/2018Open, Classified |
| Z-2661-2018 Class II | Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be…The spreader bar can detach from the scale attachment under certain conditions. | Arjohuntleigh Magog | 02/12/2018Terminated |
| Z-2660-2018 Class II | Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be…The spreader bar can detach from the scale attachment under certain conditions. | Arjohuntleigh Magog | 02/12/2018Terminated |
| Z-0013-2018 Class II | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C poweredDuring internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts… | Handicare Usa Inc | 09/08/2017Terminated |
| Z-1406-2017 Class II | A-series lift - A625 Manual Part No. 324117. Prism Medical.During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | ErgoSafe Products, LLC (DBA) Prism Medical | 01/30/2017Terminated |
| Z-1405-2017 Class II | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. | ErgoSafe Products, LLC (DBA) Prism Medical | 01/30/2017Terminated |
| Z-0728-2017 Class II | Carry bar which is an accessory to a lift used for patients in hospitals and other…The black plastic puck on the carry bar is breaking resulting in potential for patient harm. | ErgoSafe Products, LLC (DBA) Prism Medical | 08/30/2016Terminated |
| Z-0326-2017 Class II | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail…Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if… | Hill-Rom, Inc. | 08/09/2016Terminated |
| Z-0014-2018 Class II | Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012…A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin… | Handicare AB | 07/28/2016Terminated |
| Z-2291-2016 Class II | Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC…Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. | Moller Vital | 06/24/2016Terminated |