The following data is part of a premarket notification filed by Pepin Mfg., Inc. with the FDA for Pmi Tens Electrode.
| Device ID | K932849 |
| 510k Number | K932849 |
| Device Name: | PMI TENS ELECTRODE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Jeff Solberg |
| Correspondent | Jeff Solberg PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-10 |
| Decision Date | 1994-01-27 |