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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K113321
Device Name TENS BACK PAIN RELIEF SYSTEM
Applicant
SAVIA LIMITED
11820 RED HIBISCUS
BONITA SPRINGS,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
SAVIA LIMITED
11820 RED HIBISCUS
BONITA SPRINGS,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/10/2011
Decision Date 09/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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