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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

Recent recalls

DateFirmReason
2025-01-17Zhejiang Luyao Electronics Technology Co., Ltd.Regulatory documentation error and misleading color packaging claim.
2023-03-07Compass 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
2017-01-13Won Industry Co.Distribution of unapproved devices with incorrect air compression level setup
2017-01-13Won Industry Co.Distribution of unapproved devices with incorrect air compression level setup
2011-08-23CoolSystems, 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.