510(k) K071050 ยท IRP Massager, Powered Inflatable Tube
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
| Applicant | Coolsystems, Inc., Berkeley CA, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | Apr 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.