§890.1450. Powered reflex hammer.
21 C.F.R. § 890.1450
Identification. A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.
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 § 890.9.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]