Home / 510(k) Clearances / K971855

510(k) K971855

POTTY PAL AND FOREVER-DRY by Digital Applications, Inc. — Product Code KPN

K971855 is an FDA 510(k) premarket notification submitted by Digital Applications, Inc. for the device "POTTY PAL AND FOREVER-DRY". The FDA issued a decision of Substantially Equivalent on August 18, 1997. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
May 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type

Other clearances for product code KPN

  • K130951 — SIM (August 22, 2013)
  • K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M (January 8, 1998)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)
  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)
  • K934369 — DRI SLEEPER (November 24, 1993)

FDA data resources