---
kind: "section"
citation: "21 C.F.R. § 890.5760"
title: "21"
number: "890.5760"
heading: "Nonpowered lower extremity pressure wrap."
url: "https://uscodex.org/cfr/21/890.5760"
---

# §890.5760. Nonpowered lower extremity pressure wrap.

- (a) **Identification.** A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.
- (b) **Classification.** Class I (general 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 [§ 890.9](/cfr/21/890.9.md).

## Notes

### Amendments

[79 FR 37950, July 3, 2014]

### 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

[79 FR 37950, July 3, 2014]