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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, Over-The-Counter
510(k) Number K091757
FOIA Releasable 510(k) K091757
Device Name OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Applicant
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Applicant Contact JENNY HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Correspondent Contact JENNY HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Date Received06/16/2009
Decision Date 02/05/2010
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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