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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K020314
Device Name DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
Applicant
Well-Life Healthcare, Inc.
#5 Aly. 5 Ln. 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 Aly. 5 Ln. Cheng Hsing
Chung Ching Rd., Pei Tun Dist.
Taichung, R.O.C.,  TW
Correspondent Contact TONY C.S. CHANG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/30/2002
Decision Date 04/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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