Regulation Text
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.