FDA product code PTB

Ataxiagraph With Interpretive Software

Neurology·Class 1·21 CFR 882.1030
US regulatory classifications
US Product Code (FDA)
PTB
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 882.1030
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Ataxiagraph With Interpretive Software is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.