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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K101217
Device Name MAC-MOBILE AQUATIC CHAIR
Applicant
Rehamed Intl., LLC
522 W. Mowry Dr.
Homestead,  FL  33030
Applicant Contact JOHN CADEN
Correspondent
Rehamed Intl., LLC
522 W. Mowry Dr.
Homestead,  FL  33030
Correspondent Contact JOHN CADEN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/30/2010
Decision Date 06/23/2010
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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