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`FDA Home3 Medical Devices4 Databases5
`CFR - Code of Federal Regulations Title 21
`The information on this page is current as of April 1 2019.
`For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations
`(eCFR).6
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`[Code of Federal Regulations]
`[Title 21, Volume 8]
`[Revised as of April 1, 2019]
`[CITE: 21CFR884.5960]
`
`Help7 | More About 21CFR 8
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`9
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`TITLE 21--FOOD AND DRUGS
`CHAPTER I--FOOD AND DRUG ADMINISTRATION
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`SUBCHAPTER H - MEDICAL DEVICES
`PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES
`Subpart F - Obstetrical and Gynecological Therapeutic Devices
`Sec. 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]
`
`Links on this page:
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`3. https://www.fda.gov/
`4. https://www.fda.gov/MedicalDevices/default.htm
`5. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases
`/default.htm
`6. https://www.ecfr.gov/cgi-bin/ECFR?page=browse
`7. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true
`8. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases
`/ucm135680.htm
`9. /scripts/cdrh/devicesatfda
`/index.cfm?Search_Term=Genital%20vibrator%20for%20therapeutic%20use%2E
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`CFR - Code of Federal Regulations Title 21
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`https://www.accessdata fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm...
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`Links on this page:
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`4. https://www.fda.gov/MedicalDevices/default.htm
`5. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases
`/default.htm
`6. https://www.ecfr.gov/cgi-bin/ECFR?page=browse
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`8. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases
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