21 CFR § 882.1020
Rigidity analyzer
June 25, 2020
(a) 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.
(b) 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.
[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]
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