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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K070890
Device Name EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
Applicant
Everlife Medical Equipment Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
Everlife Medical Equipment Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number882.5890
Classification Product Code
LIH  
Date Received03/30/2007
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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