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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 K100399
Device Name 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
Applicant
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Applicant Contact JENNY HSEIH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Correspondent Contact JENNY HSEIH
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received02/16/2010
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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