KPN — Alarm, Conditioned Response Enuresis Class II
FDA product code KPN covers "Alarm, Conditioned Response Enuresis", a Class II medical device regulated under 21 CFR 876.2040. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPN
- Device Class
- Class II
- Regulation Number
- 876.2040
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130951 | simavita pty limited | SIM | August 22, 2013 |
| K971442 | humed | HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M | January 8, 1998 |
| K971855 | digital applications | POTTY PAL AND FOREVER-DRY | August 18, 1997 |
| K962770 | princeton regulatory assoc | UROSURGE ACUTRAINER | August 1, 1996 |
| K962416 | bio-systems research | DRYTIME FOR BLADDER CONTROL SILENT | July 22, 1996 |
| K955338 | health sense intl | DRYTIME FOR POTTY TRAINING | March 12, 1996 |
| K943558 | health sense intl | PRO'TECT | May 24, 1995 |
| K943559 | health sense intl | REMOTE A'LERT | May 24, 1995 |
| K942057 | fisher price | FISHER-PRICE DRY NIGHT MONITOR | July 28, 1994 |
| K935915 | edson | WET SENSE | May 13, 1994 |
| K934369 | laborie medical technologies | DRI SLEEPER | November 24, 1993 |
| K930005 | laborie medical technologies | DRITRAINER | March 3, 1993 |
| K921431 | ideas for living | POTTY PAGER | July 21, 1992 |
| K911279 | health sense intl | DRY TIME | September 4, 1991 |
| K901907 | travis industries | PROFESSIONAL MONITOR | September 12, 1990 |
| K903856 | travis industries | WET-NO-MORE MONITOR | September 12, 1990 |
| K901906 | travis industries | WET-NO-MORE MONITOR | July 11, 1990 |
| K895852 | med-design | BUZZY BEAR ENURESIS ALARM | February 12, 1990 |
| K895251 | c.r. bard | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | November 13, 1989 |
| K895346 | intellitech | DR. DRY | October 24, 1989 |