ManaCold Compression System
FDA 510(k) K260944 · Manamed, LLC
510(k) numberK260944
Submission
- Device name
- ManaCold Compression System
- Applicant
- Manamed, LLC
Denton, TX, US - Received
- March 23, 2026
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| 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 |
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| 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 |
More from Shenzhen Future Electronic Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | 09/17/2025SE |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUH · Traditional | 11/03/2023SE |
| K222098 | ManaSport+IMI · Traditional | 03/08/2023SE |
| K210284 | ManaSportIMI · Traditional | 04/26/2022SE |
| K211253 | PlasmaWaveJOW · Special | 05/26/2021SE |
| K200353 | ManaFlowJOW · Traditional | 08/06/2020SE |
| K200351 | PlasmaFlightIRP · Traditional | 08/05/2020SE |
| K160318 | PlasmaFlowJOW · Traditional | 04/01/2016SE |
Questions and answers
When was ManaCold Compression System cleared by the FDA?
ManaCold Compression System (K260944) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 142 days after the submission was received.
What is the product code of K260944?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.