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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 884 - Obstetrical and Gynecological Devices |
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Subpart F - Obstetrical and Gynecological Therapeutic Devices |
§ 884.5960 - Genital vibrator for therapeutic use.
Latest version.
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§ 884.5960 Genital vibrator for therapeutic use.
(a) Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).
(b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.
[45 FR 12684, Feb. 26, 1980, as amended at 83 FR 29215, June 5, 2018]