21 CFR § 890.1450
Powered reflex hammer
June 25, 2020
(a) Identification. A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.
(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 §890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
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