510(k) K090951 ยท GXY Electrode, Cutaneous
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
| Applicant | Rs Medical, Vancouver WA, US |
| Decision | Substantially Equivalent, Jun 5, 2009 |
| Received | Apr 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2010 | International Rehabilitative Sciences, Inc. The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle s Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.