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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 K970429
Device Name BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
Applicant
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN,  TW
Applicant Contact DANIEL LEE
Correspondent
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN,  TW
Correspondent Contact DANIEL LEE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/04/1997
Decision Date 04/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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