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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 K021359
Device Name DIGI-PRO TENS MODEL WL-2203 AND WL-2205
Applicant
WELL-LIFE HEALTHCARE, INC.
NO. 5 ALLEY 5 LANE CHENG HSING
CHUNG CHING RD., PEI TUN DIST.
TAICHUNG,  TW
Applicant Contact TONY C.S. CHANG
Correspondent
WELL-LIFE HEALTHCARE, INC.
NO. 5 ALLEY 5 LANE CHENG HSING
CHUNG CHING RD., PEI TUN DIST.
TAICHUNG,  TW
Correspondent Contact TONY C.S. CHANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/30/2002
Decision Date 04/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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