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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K092763
Device Name IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
Applicant
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Applicant Contact JENNY HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Correspondent Contact JENNY HSIEH
Regulation Number882.5890
Classification Product Code
LIH  
Date Received09/09/2009
Decision Date 10/08/2009
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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