The following data is part of a premarket notification filed by Empi with the FDA for Empi Single Use.
| Device ID | K822224 |
| 510k Number | K822224 |
| Device Name: | EMPI SINGLE USE |
| Classification | Electrode, Cutaneous |
| Applicant | EMPI 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-08-16 |