---
kind: "section"
citation: "21 C.F.R. § 890.5940"
title: "21"
number: "890.5940"
heading: "Chilling unit."
url: "https://uscodex.org/cfr/21/890.5940"
---

# §890.5940. Chilling unit.

- (a) **Identification.** A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.
- (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

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]

### 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 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]