510(k) K902195 ยท GXY Electrode, Cutaneous
TBD TENS REUSABLE ELECTRODE
| Applicant | Empi, Arden Hills MN, US |
| Decision | Substantially Equivalent, Jun 8, 1990 |
| Received | May 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological s Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.