---
kind: "section"
citation: "21 C.F.R. § 890.5100"
title: "21"
number: "890.5100"
heading: "Immersion hydrobath."
url: "https://uscodex.org/cfr/21/890.5100"
---

# §890.5100. Immersion hydrobath.

- (a) **Identification.** An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
- (b) **Classification.** Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, 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 [§ 890.9](/cfr/21/890.9.md).

## Notes

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

### Authority

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

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]