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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.
#5 Alley 5 Lane Cheng Hsing
Chung Ching Rd., Pei Tun Dist.
Taichung, R.O.C.,  TW
Applicant Contact TONY C.S. 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.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
Predetermined Change
Control Plan Authorized		 No
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