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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K011744
Device Name HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
Applicant
Transworld Mobility Distribution, LLC
6140 Mild Metro Dr.
Suite #6
Fort Myers,  FL  33912
Applicant Contact JUAN C RIVERA
Correspondent
Transworld Mobility Distribution, LLC
6140 Mild Metro Dr.
Suite #6
Fort Myers,  FL  33912
Correspondent Contact JUAN C RIVERA
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/05/2001
Decision Date 08/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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