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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 K080288
Device Name TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
Applicant
Mega Motion, Inc.
957 Wood St.
Old Forge,  PA  18518
Applicant Contact TOM AMICO
Correspondent
Mega Motion, Inc.
957 Wood St.
Old Forge,  PA  18518
Correspondent Contact TOM AMICO
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/04/2008
Decision Date 02/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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