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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 K994107
Device Name AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
Applicant
Amylior, Inc.
6 Antoine-Henault
Note-Dame Of Ile Perrot,Quebec,  CA J7V 7M3
Applicant Contact SYLVAIN DUGAS
Correspondent
Amylior, Inc.
6 Antoine-Henault
Note-Dame Of Ile Perrot,Quebec,  CA J7V 7M3
Correspondent Contact SYLVAIN DUGAS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/06/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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