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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 K042107
Device Name TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
Applicant
TUNG FU ELECTRIC CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
TUNG FU ELECTRIC CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/04/2004
Decision Date 03/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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