PTB

Ataxiagraph With Interpretive Software

Product code: PTB
Device name: Ataxiagraph With Interpretive Software
Device class: Class 1
21 CFR: 21 CFR 882.1030
Medical specialty: Neurology
Marketing pathway: 510(K)
Flag: Third-party review eligible

FDA classification definition

Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement.

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

Official FDA classification page: PTB

Classification and pathway per current FDA publications. Data from openFDA (CC0).