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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 FL., STE 504,EMPIRE CENTRE
68 MODY ROAD, TSIMSHATSUIM
KOWLOON,  HK
Applicant Contact GRACE CHANG
Correspondent
WELL-LIFE HEALTHCARE LIMITED
5 FL., STE 504,EMPIRE CENTRE
68 MODY ROAD, 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
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