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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K881681
Device Name CYBEX BACK TESTING AND REHABILITATION SYSTEM
Applicant
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Applicant Contact WILLIAM SAUER
Correspondent
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Correspondent Contact WILLIAM SAUER
Regulation Number890.1925
Classification Product Code
IKK  
Date Received04/19/1988
Decision Date 04/25/1990
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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