KPN · Alarm, Conditioned Response Enuresis
Gastroenterology, Urology · 21 CFR 876.2040 · Class 2
Overview
| Product Code | KPN |
|---|---|
| Device Name | Alarm, Conditioned Response Enuresis |
| Regulation | 21 CFR 876.2040 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
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.
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130951 | SIM | Simavita Pty Limited | Aug 22, 2013 | SESE |
| K971442 | HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5 | Humed, Inc. | Jan 8, 1998 | SESE |
| K971855 | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | Aug 18, 1997 | SESE |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | Aug 1, 1996 | SESE |
| K962416 | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | Jul 22, 1996 | SESE |
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | Mar 12, 1996 | SESE |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | May 24, 1995 | SESE |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | May 24, 1995 | SESE |
| K942057 | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | Jul 28, 1994 | SESE |
| K935915 | WET SENSE | Edson Corp. | May 13, 1994 | SESE |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | Nov 24, 1993 | SESE |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | Mar 3, 1993 | SESE |
| K921431 | POTTY PAGER | Ideas For Living | Jul 21, 1992 | SESE |
| K911279 | DRY TIME | Health Sense Intl., Inc. | Sep 4, 1991 | SESE |
| K903856 | WET-NO-MORE MONITOR | Travis Industries, Inc. | Sep 12, 1990 | SESE |
| K901907 | PROFESSIONAL MONITOR | Travis Industries, Inc. | Sep 12, 1990 | SESE |
| K901906 | WET-NO-MORE MONITOR | Travis Industries, Inc. | Jul 11, 1990 | SESE |
| K895852 | BUZZY BEAR ENURESIS ALARM | Med-Design, Inc. | Feb 12, 1990 | SESE |
| K895251 | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | C.R. Bard, Inc. | Nov 13, 1989 | SESE |
| K895346 | DR. DRY | Intellitech | Oct 24, 1989 | SESE |
Top Applicants
- Health Sense Intl., Inc. — 4 clearances
- Travis Industries, Inc. — 3 clearances
- Biosonics, Inc. — 3 clearances
- Nite Train-R Enterprises, Inc. — 2 clearances
- Laborie Medical Technologies, Ltd. — 2 clearances
