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e-CFR data is current as of January 19, 2021 |
Title 21 → Chapter I → Subchapter H → Part 890 → Subpart B → §890.1450 |
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart B—Physical Medicine Diagnostic Devices
§890.1450 Powered reflex hammer.
(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]