510(k) K090308 ยท JOW Sleeve, Limb, Compressible
RESTEP DVY SYSTEM, MODEL RSP-101
| Applicant | Stortford Medical, LLC, West Windsor NJ, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Feb 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Stryker Sustainability Solutions STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor). Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.