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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 K010011
Device Name TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
Applicant
Accelerated Rehab Designs, Inc.
32025 Industrial Park Dr.
Pinehurst,  TX  77362
Applicant Contact RANDALL POTTER
Correspondent
Accelerated Rehab Designs, Inc.
32025 Industrial Park Dr.
Pinehurst,  TX  77362
Correspondent Contact RANDALL POTTER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/02/2001
Decision Date 01/12/2001
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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