21 CFR 876.2040 — Alarm, Conditioned Response Enuresis
Gastroenterology, Urology (GU) · Subpart C—Monitoring Devices · § 876.2040
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | 2 | 37 |
Special Controls
KPN — Alarm, Conditioned Response Enuresis
*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.
eCFR
