510(k) K955338

DRYTIME FOR POTTY TRAINING by Health Sense Intl., Inc. — Product Code KPN

K955338 is an FDA 510(k) premarket notification submitted by Health Sense Intl., Inc. for the device "DRYTIME FOR POTTY TRAINING". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Health Sense Intl., Inc. has at least 3 other 510(k) clearances on record.