The following data is part of a premarket notification filed by Prothia Usa, Inc. with the FDA for Myotest Nerve Stimulator.
| Device ID | K823583 |
| 510k Number | K823583 |
| Device Name: | MYOTEST NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | PROTHIA USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1982-12-30 |