Text
Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 890: PHYSICAL MEDICINE DEVICES
Subpart F: Physical Medicine Therapeutic Devices
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]
Sponsored links
