Kneu Platform (V2)
Device Facts
| Record ID | K262515 |
|---|---|
| Device Name | Kneu Platform (V2) |
| Applicant | Kneu Health Digital , Ltd. |
| Product Code | GYD · Neurology |
| Decision Date | Aug 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1950 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.