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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 K955274
Device Name BOOSTER LITE 3 MOTORIZED SCOOTER
Applicant
Optimed Technologies, Inc.
300 K St., NW
Suite 500
Washington,  DC  20007
Applicant Contact ILENE G OTTS
Correspondent
Optimed Technologies, Inc.
300 K St., NW
Suite 500
Washington,  DC  20007
Correspondent Contact ILENE G OTTS
Regulation Number890.3800
Classification Product Code
INI  
Date Received11/15/1995
Decision Date 11/04/1996
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
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