e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart B → §882.1020 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices
(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]