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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 K080304
Device Name PRO TENS, MODEL WL-240 RX
Applicant
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Applicant Contact JENNY HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Correspondent Contact JENNY HSIEH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/05/2008
Decision Date 06/20/2008
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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