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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 K052785
Device Name OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
Applicant
Well-Life Healthcare Limited
5 Floor , Suite 504 Empire Centre
68 Mody Rd., Tsimshatsuim
Kowloon,  HK
Applicant Contact GRACE CHANG
Correspondent
Well-Life Healthcare Limited
5 Floor , Suite 504 Empire Centre
68 Mody Rd., Tsimshatsuim
Kowloon,  HK
Correspondent Contact GRACE CHANG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received10/03/2005
Decision Date 03/17/2006
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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