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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 K864686
Device Name SCOOTA MOTORIZED VEHICLE
Applicant
A-Bec Mobility, Inc.
20460 Gramercy Pl.
Torrance,  CA  90501
Applicant Contact KEITH PAYNE
Correspondent
A-Bec Mobility, Inc.
20460 Gramercy Pl.
Torrance,  CA  90501
Correspondent Contact KEITH PAYNE
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/02/1986
Decision Date 12/16/1986
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
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