← Product Code [KPN](/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN) · K821546

# MONITORING DEVICE ENURESIS ALARM & ACC. (K821546)

_Wetbell, Inc. · KPN · Jun 9, 1982 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K821546

## Device Facts

- **Applicant:** Wetbell, Inc.
- **Product Code:** [KPN](/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN.md)
- **Decision Date:** Jun 9, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.2040
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## 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 § 876.9.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K821546](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K821546)

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