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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePTB
Regulation Number 882.1030
Device Class 1