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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 K854710
Device Name BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID
Applicant
Reloke Co.
8919 Sunset Blvd.
Los Angeles,  CA  90069
Applicant Contact AIRLINE MILLER
Correspondent
Reloke Co.
8919 Sunset Blvd.
Los Angeles,  CA  90069
Correspondent Contact AIRLINE MILLER
Regulation Number890.3920
Classification Product Code
KNN  
Date Received11/21/1985
Decision Date 04/16/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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