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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 890 - Physical Medicine Devices |
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Subpart B - Physical Medicine Diagnostic Devices |
§ 890.1450 - Powered reflex hammer.
Latest version.
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§ 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 (performance standards). 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]