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Massager, Powered Inflatable Tube
FDA product code IRP · Class 2 · Physical Medicine
1,206
Registered devices
38
Adverse events
5
Recalls
158
510(k) clearances
Devices with this code
Game Ready GRPRO 2.1 Control Unit Education — Avanos Medical, Inc.Rapid Reboot — RAPID REBOOT RECOVERY PRODUCTS LLCPulse User Manual — NORMATEC INDUSTRIES LPStockinet — NORMATEC INDUSTRIES LPVU — Xiamen Weiyou Intelligent Technology Co.,LtdCompressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO.,LTD.LX9max — DAESUNG MAREF CO.,LTD.Compressible Limb Therapy System — DAESUNG MAREF CO.,LTD.Game Ready — Avanos Medical, Inc.Power Cord — NORMATEC INDUSTRIES LPNormaTec MVP Upper and Lower Body Recovery Package — NORMATEC INDUSTRIES LPTherm-X — ZENITH TECHNICAL INNOVATIONS, LLCNormaTec MVP Lower Body Recovery Package — NORMATEC INDUSTRIES LPGame Ready — Avanos Medical, Inc.Bio Compression Systems Cryo Insert Large - Black — Bio Compression Systems, IncNormaTec MVP Lower Body Recovery Package — NORMATEC INDUSTRIES LPCompressible Limb Therapy System(Lympha-Flow(LF400)) — DAESUNG MAREF CO.,LTD.Blue Boot — NORMATEC INDUSTRIES LP4 chamber sleeve — DAESUNG MAREF CO.,LTD.LF400 — DAESUNG MAREF CO.,LTD.N/A — Shenzhen Urion Technology Co., LtdSquid — PORTABLE THERAPEUTIX4 chamber extension zipper — DAESUNG MAREF CO.,LTD.LF900 — DAESUNG MAREF CO.,LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | Zhejiang Luyao Electronics Technology Co., Ltd. | Regulatory documentation error and misleading color packaging claim. |
| 2023-03-07 | Compass Health Brands (Corporate Office) | Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2017-01-13 | Won Industry Co. | Distribution of unapproved devices with incorrect air compression level setup |
| 2011-08-23 | CoolSystems, Inc. | It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadverten |
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