Product Classification

• Device: ataxiagraph with interpretive software
• Regulation Description: Ataxiagraph.
• 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.
• Physical State: Sensors applied to the body and software to analyze and interpret the signals.
• Technical Method: Sensors applied to the body and software to analyze and interpret the signals.
• Target Area: Trunk and extremities
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: PTB
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.1030
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc