Kneu Platform (V2)— 510(k) K262515
Substantially EquivalentKneu Health Digital , Ltd.
FDA 510(k) clearance K262515 for Kneu Platform (V2), Substantially Equivalent on 2026-08-20. Applicant: Kneu Health Digital , Ltd.. Device class: 2.
Summary
Kneu Health Digital filed Kneu Platform (V2) under product code GYD, tremor transducers. The record doesn't describe the platform beyond its name and that code.
Class II, 21 CFR 882.1950. Neurology is both the classification panel and the review panel. It was a Traditional 510(k), and the record flags it as a third-party review.
Kneu filed from London, United Kingdom. The decision came 30 calendar days after FDA received it (July 21 to August 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Kneu Health Digital , Ltd.
- Product code
- Product code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
Recent devices under product code GYD
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