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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 K992828
Device Name E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
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 Received08/23/1999
Decision Date 02/03/2000
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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