PTB · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.1030
Classification
FDA Product Code
PTB
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 882.1030
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.