---
kind: "section"
citation: "21 C.F.R. § 876.2040"
title: "21"
number: "876.2040"
heading: "Enuresis alarm."
url: "https://uscodex.org/cfr/21/876.2040"
---

# §876.2040. Enuresis alarm.

- (a) **Identification.** An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.
- (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 [§ 876.9](/cfr/21/876.9.md).

## Notes

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]

### Authority

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

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]