---
kind: "section"
citation: "21 C.F.R. § 884.5390"
title: "21"
number: "884.5390"
heading: "Perineal heater."
url: "https://uscodex.org/cfr/21/884.5390"
---

# §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 (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]