The following data is part of a premarket notification filed by Noraxon Usa, Inc. with the FDA for Myotrace 10 Biofeedback Device.
| Device ID | K895633 |
| 510k Number | K895633 |
| Device Name: | MYOTRACE 10 BIOFEEDBACK DEVICE |
| Classification | Device, Biofeedback |
| Applicant | NORAXON USA, INC. 8381 E. GELDING RD. Scottsdale, AZ 85260 |
| Contact | Sipila, Md |
| Correspondent | Sipila, Md NORAXON USA, INC. 8381 E. GELDING RD. Scottsdale, AZ 85260 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-19 |
| Decision Date | 1990-04-13 |