Product code PTB

Device name

Ataxiagraph With Interpretive Software

Medical specialty

Neurology

Device class

1

Regulation number

882.1030

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset