Title 21

SECTION 882.1030

882.1030 Ataxiagraph.

§ 882.1030 Ataxiagraph.

(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.

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019]