TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4

Vehicle, Motorized 3-wheeled

MERITS HEALTH PRODUCTS., INC.

The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Travel Ease Electric Scooter, Model Pioneer 4.

Pre-market Notification Details

Device IDK011753
510k NumberK011753
Device Name:TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
ClassificationVehicle, Motorized 3-wheeled
Applicant MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral,  FL  33915
ContactWinston Anderson
CorrespondentWinston Anderson
MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral,  FL  33915
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-06
Decision Date2001-08-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04714379291834 K011753 000
04714379291803 K011753 000
04714379291797 K011753 000
04714379291766 K011753 000
04714379291759 K011753 000
04714379291742 K011753 000
04714379291186 K011753 000
04714379291124 K011753 000
04714379291117 K011753 000

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