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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 K860521
Device Name STANDARD WHEELCHAIRS
Applicant
Formotion, Inc.
96 Smedley Rd.
Fairfield,  CT  06430
Applicant Contact COVERT HARRIS
Correspondent
Formotion, Inc.
96 Smedley Rd.
Fairfield,  CT  06430
Correspondent Contact COVERT HARRIS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/11/1986
Decision Date 03/10/1986
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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