510(k) K192358 ยท IRP Massager, Powered Inflatable Tube
Pressure Therapy System PT1003
| Applicant | Xiamen Senyang Co., Ltd., Xinglin Xiamen, CN |
| Decision | Substantially Equivalent, Apr 23, 2020 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.