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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K861754
Device Name KINESETHETIC SEATING SYSTEM/WHEELCHAIR
Applicant
Special Health Systems, Ltd.
1089 Gordon Dr., Kelowna
B.C. V1y 3e3,  CA
Applicant Contact JUDY LOUKRAS
Correspondent
Special Health Systems, Ltd.
1089 Gordon Dr., Kelowna
B.C. V1y 3e3,  CA
Correspondent Contact JUDY LOUKRAS
Regulation Number890.3920
Classification Product Code
KNN  
Date Received05/06/1986
Decision Date 05/23/1986
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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