K222101 is an FDA 510(k) clearance for the Prism. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Graymatters Health , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 17, 2023, 242 days after receiving the submission on July 18, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K222101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 242 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 |