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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K952042
Device Name TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
Applicant
Merits Health Products Co., Ltd.
505 N. Del Prado
Cape Copral,  FL  33909
Applicant Contact NANCY ANDERSON
Correspondent
Merits Health Products Co., Ltd.
505 N. Del Prado
Cape Copral,  FL  33909
Correspondent Contact NANCY ANDERSON
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/01/1995
Decision Date 03/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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