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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.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
Tung FU Electric Co., Ltd.
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
Predetermined Change
Control Plan Authorized		 No
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