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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 K012792
Device Name C.T.M. MOBITIY SCOOTER MODEL #HS-360
Applicant
WAREPALMY ENTERPRISE LLC (USA)
3636 EAST COLUMBINE DR.
PHOENIX,  AZ  85032 -7372
Applicant Contact ROBERT S MCQUATE
Correspondent
WAREPALMY ENTERPRISE LLC (USA)
3636 EAST COLUMBINE DR.
PHOENIX,  AZ  85032 -7372
Correspondent Contact ROBERT S MCQUATE
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/20/2001
Decision Date 10/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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