510(k) clearance

Kneu Platform (V2)

FDA 510(k) source

510(k) number

K262515

Applicant

Kneu Health Digital , Ltd.

Decision date

Aug 20, 2026

Date received

Jul 21, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GYD

Device type

Transducer, Tremor

Device class

Class II

Regulation

21 CFR 882.1950

Advisory committee

Neurology

Statement or summary

Summary

Third party

Y

Location

London, GB