PTB — Ataxiagraph With Interpretive Software Class I
FDA product code PTB covers "Ataxiagraph With Interpretive Software", a Class I medical device regulated under 21 CFR 882.1030. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- PTB
- Device Class
- Class I
- Regulation Number
- 882.1030
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.