The following data is part of a premarket notification filed by Covidien Lp with the FDA for Tens/nmes/fes Stimulating Electrode.
| Device ID | K083350 |
| 510k Number | K083350 |
| Device Name: | TENS/NMES/FES STIMULATING ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | COVIDIEN LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Wei Zhao |
| Correspondent | Wei Zhao COVIDIEN LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2009-04-21 |
| Summary: | summary |