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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K934175
Device Name STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER
Applicant
Orthopedic Development, Inc.
1700 S. Park St., Suite 201
Kalamazoo,  MI  49001
Applicant Contact ALAN A HALPERN
Correspondent
Orthopedic Development, Inc.
1700 S. Park St., Suite 201
Kalamazoo,  MI  49001
Correspondent Contact ALAN A HALPERN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received08/26/1993
Decision Date 03/24/1994
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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