GWW

Ataxiagraph

Product code
GWW
Device name
Ataxiagraph
Device class
Class 1
21 CFR
21 CFR 882.1030
Medical specialty
Neurology
Marketing pathway
510(K) Exempt

FDA classification definition

Exemption is limited to devices that do not provide an interpretation or a clinical implication of the measurement.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: GWW
Classification and pathway per current FDA publications. Data from openFDA (CC0).