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PTBClass I

Ataxiagraph With Interpretive Software

21 CFR 882.1030 / Neurology
FDA source (opens on fda.gov)

PTB is the FDA product code for Ataxiagraph With Interpretive Software, a class I device type, regulated under 21 CFR 882.1030. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PTB
Device name
Ataxiagraph With Interpretive Software
FDA 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.
Regulation
21 CFR 882.1030
Device class
Class I
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PTB.