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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, for pain relief
510(k) Number K021755
Device Name APEX MEDICAL DIGITAL TENS TS1211, TS1212
Applicant
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN,  TW
Applicant Contact ALAN CHANG
Correspondent
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN,  TW
Correspondent Contact ALAN CHANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/29/2002
Decision Date 06/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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