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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 K884487
Device Name LIDO TM ACTIVE BACK
Applicant
Loredan Biomedical, Inc.
1632 Da Vinci Ct.
P.O. Box 1154
Davis,  CA  95616
Applicant Contact KAREN COMISSO
Correspondent
Loredan Biomedical, Inc.
1632 Da Vinci Ct.
P.O. Box 1154
Davis,  CA  95616
Correspondent Contact KAREN COMISSO
Regulation Number890.1925
Classification Product Code
IKK  
Date Received10/25/1988
Decision Date 11/18/1988
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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