The following data is part of a premarket notification filed by Empi with the FDA for Tensmate Empimodel 9980.
| Device ID | K802507 |
| 510k Number | K802507 |
| Device Name: | TENSMATE EMPIMODEL 9980 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-12-01 |