§882.1020. Rigidity analyzer.
21 C.F.R. § 882.1020
Identification. A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Notes, amendments, and revision history
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]