HHA · Heater, Perineal, Radiant, Non-Contact
Obstetrics/Gynecology · 21 CFR 884.5390 · Class 2
Overview
| Product Code | HHA |
|---|---|
| Device Name | Heater, Perineal, Radiant, Non-Contact |
| Regulation | 21 CFR 884.5390 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
