K250153 is an FDA 510(k) clearance for the Neu Platform. This device is classified as a Transducer, Tremor (Class II - Special Controls, product code GYD).
Submitted by Neuhealth Digital , Ltd. (London, GB). The FDA issued a Cleared decision on April 25, 2025, 94 days after receiving the submission on January 21, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1950.
| 510(k) Number | K250153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | April 25, 2025 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYD - Transducer, Tremor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1950 |