510(k) K003815

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER by Merits Health Products., Inc. — Product Code INI

K003815 is an FDA 510(k) premarket notification submitted by Merits Health Products., Inc. for the device "TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER". The FDA issued a decision of Substantially Equivalent on Dec 27, 2000. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Merits Health Products., Inc. has 11 other 510(k) clearances on record.