The following data is part of a premarket notification filed by American Imex with the FDA for Premier 10s (tens).
| Device ID | K881424 |
| 510k Number | K881424 |
| Device Name: | PREMIER 10S (TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AMERICAN IMEX 16520 ASTON ST. Irvine, CA 92606 |
| Contact | Joan Fong |
| Correspondent | Joan Fong AMERICAN IMEX 16520 ASTON ST. Irvine, CA 92606 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-05 |
| Decision Date | 1988-04-11 |