REMOTE A'LERT
Device Facts
| Record ID | K943559 |
|---|---|
| Device Name | REMOTE A'LERT |
| Applicant | Health Sense Intl., Inc. |
| Product Code | KPN · Gastroenterology, Urology |
| Decision Date | May 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.2040 |
| Device Class | Class 2 |
Regulatory Classification
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.
