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Alarm, Conditioned Response Enuresis
- Page Type
- Product Code
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 876.2040
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.2040 Enuresis alarm
§ 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 of this chapter subject to § 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]