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Code of Federal Regulations (Last Updated: April 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 882 - Neurological Devices |
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Subpart B - Neurological Diagnostic Devices |
§ 882.1020 - Rigidity analyzer.
Latest version.
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§ 882.1020 Rigidity analyzer.
(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 (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 § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]