Home › Device types › IRP
Massager, Powered Inflatable Tube
FDA product code IRP · Class 2 · Physical Medicine
1,179
Registered devices
38
Adverse events
5
Recalls
156
510(k) clearances
Devices with this code
Rapid Reboot — RAPID REBOOT RECOVERY PRODUCTS LLCPulse Lower Body Recovery Package — NORMATEC INDUSTRIES LPTherm-X — ZENITH TECHNICAL INNOVATIONS, LLCBlue Boot — NORMATEC INDUSTRIES LPPower Supply — NORMATEC INDUSTRIES LPRapid Reboot — RAPID REBOOT RECOVERY PRODUCTS LLCHOMEDICS — FKA DISTRIBUTING CO., LLCGame Ready Ankle Heat Exchanger - Large- Rental — Avanos Medical, Inc.NormaTec MVP Full Body Body Recovery Package — NORMATEC INDUSTRIES LPCompressible Limb Therapy System(MK300L) — DAESUNG MAREF CO.,LTD.Pulse Pro Full Body Recovery Package — NORMATEC INDUSTRIES LPGame Ready — Avanos Medical, Inc.Therm-X — ZENITH TECHNICAL INNOVATIONS, LLCVU — Xiamen Weiyou Intelligent Technology Co.,LtdSP-2000 — DAESUNG MAREF CO.,LTD.Pulse Full Body Recovery Package — NORMATEC INDUSTRIES LPCompressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO.,LTD.Game Ready — Avanos Medical, Inc.Stockinet — NORMATEC INDUSTRIES LPNeuroglide Back Neck Pad — Eva Medtec, IncTherm-X — ZENITH TECHNICAL INNOVATIONS, LLCMueller Sports Medicine — Mueller Sports Medicine, Inc.Compressible Limb Therapy System(Lympha-Flow(LF400)) — DAESUNG MAREF CO.,LTD.Squid Go — PORTABLE THERAPEUTIX
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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