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U.S. Department of Health and Human Services

Product Classification

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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 CodePTB
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type 510(k)
Regulation Number 882.1030
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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