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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 K121353
Device Name MINI PATCH
Applicant
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW CH
Applicant Contact CHIN-CHIN HSIEH
Correspondent
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW CH
Correspondent Contact CHIN-CHIN HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/04/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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