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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 K881452
Device Name FOLDING WHEELCHAIR
Applicant
Health Care Innovations, Inc.
129 S. Abbe Rd.
P.O. Box 240
Elyria,  OH  44035
Applicant Contact KEN MURPHY
Correspondent
Health Care Innovations, Inc.
129 S. Abbe Rd.
P.O. Box 240
Elyria,  OH  44035
Correspondent Contact KEN MURPHY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/06/1988
Decision Date 04/21/1988
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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