510(k) K901575 ยท GXY Electrode, Cutaneous
REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
| Applicant | Pioneering Technologies, Inc., Wabasha MN, US |
| Decision | Substantially Equivalent, May 2, 1990 |
| Received | Apr 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiol Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.