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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 K951351
Device Name X2000 TRADITIONAL WHEELCHAIR
Applicant
Homecrest Industries
1129 Bloomfield Acenue
West Caldwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Homecrest Industries
1129 Bloomfield Acenue
West Caldwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/23/1995
Decision Date 04/26/1995
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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