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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR890.5975]
See Related Information on Therapeutic vibrator. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart F--Physical Medicine Therapeutic Devices

Sec. 890.5975 Therapeutic vibrator.

(a) Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.

(b) Classification. Class I (general 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 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]

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