21 CFR 882.1030
§ 882.1030 Ataxiagraph.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.1030, § 882.1030 Ataxiagraph, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90628
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Full text
(a) Identification. An ataxiagraph is a 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.
(b) Classification. Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.