The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Emg Biofeedback Device.
| Device ID | K823511 |
| 510k Number | K823511 |
| Device Name: | EMG BIOFEEDBACK DEVICE |
| Classification | Device, Biofeedback |
| Applicant | NEMECTRON MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-29 |
| Decision Date | 1983-03-31 |