21 CFR 884.5390 - Perineal heater.

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 884: OBSTETRICAL AND GYNECOLOGICAL DEVICES

Subpart F: Obstetrical and Gynecological Therapeutic Devices

884.5390 - Perineal heater.

(a) Identification. A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surface of the perineum (the area between the vulva and the anus) and is used to soothe or to help heal the perineum after an episiotomy (incision of the vulvar orifice for obstetrical purposes).

(b) Classification. Class II (performance standards).

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