K915858 is an FDA 510(k) clearance for the MYOTRAC2. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on September 9, 1992, 257 days after receiving the submission on December 27, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K915858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1991 |
| Decision Date | September 09, 1992 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HCC — Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |