K954737 is an FDA 510(k) clearance for the SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by J-Tech, Inc. (Alpine, US). The FDA issued a Cleared decision on July 3, 1996, 261 days after receiving the submission on October 16, 1995.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K954737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1995 |
| Decision Date | July 03, 1996 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCC — Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |