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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 K060222
Device Name LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
Applicant
Gemore Technology Co, Ltd.
11 Floor , #29-5, Sec.2, Chung Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Applicant Contact BODEN S.P. LAI
Correspondent
Gemore Technology Co, Ltd.
11 Floor , #29-5, Sec.2, Chung Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Correspondent Contact BODEN S.P. LAI
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/30/2006
Decision Date 04/28/2006
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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