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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 K020020
FOIA Releasable 510(k) K020020
Device Name THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
Applicant
Well-Life Healthcare, Inc.
#5 Alley 5 Lane Cheng Hsing
Chung Ching Rd., Pei Tun Dist.
Taichung, R.O.C.,  TW
Applicant Contact TONY C CHANG
Correspondent
Well-Life Healthcare, Inc.
#5 Alley 5 Lane Cheng Hsing
Chung Ching Rd., Pei Tun Dist.
Taichung, R.O.C.,  TW
Correspondent Contact TONY C CHANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/03/2002
Decision Date 12/30/2002
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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