Panels › Physical Medicine › Product code IRP · Class 2
Massager, Powered Inflatable Tube
Regulation 890.5650
13510(k)s in 12 months (158 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in IRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Daesung Maref Co., Ltd. | 8 | 0 |
| NormaTec Industries, LP | 8 | 0 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | 7 | 0 |
| Mego Afek AC , Ltd. | 6 | 0 |
| Wonjin Mulsan Co., Ltd. | 5 | 0 |
| Chengdu Cryo-Push Medical Technology Co.,Ltd | 4 | 0 |
| Zenith Technical Innovations | 4 | 0 |
| Bio Compression Systems, Inc. | 3 | 0 |
| Coolsystems, Inc. | 2 | 1 |
| Jkh Health Co., Ltd. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2025 | Zhejiang Luyao Electronics Technology Co., Ltd. Brand Name: HOMEDICS
Product Name: Air Compression Leg Massager
Model/Catalog Number: SR-160HJ
Product Description: Powered Inflatable Tube Massager used on the leg.
The Air Compression Leg Massager Open, Classified |
IRP | K222949 |
| Apr 18, 2023 | Compass Health Brands (Corporate Office) REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Open, Classified |
IRP | K192358 |
| Jan 13, 2017 | Won Industry Co. Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses)
Product Usage:
Intended for limb massage utilizing air compression. It is specially designed to improve v Terminated |
IRP | K120166 |
| Jan 13, 2017 | Won Industry Co. Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336
Product Usage:
Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by Terminated |
IRP | K120166 |
| Sep 14, 2011 | CoolSystems, Inc. Game Ready Professional Therapy System,
a cryotherapy device.
Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated. Terminated |
IRP | K071050 |
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