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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, For Pain Relief
510(k) Number K070299
Device Name EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
Applicant
EZFIT TECHNOLOGY INC.
NO.42, SECTION 3, CHANG SHI RD
AN NAN DISTRICT
TAINAN CITY,  TW 709
Applicant Contact OU YANG
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact MARC M MOUSER
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IRT  
Date Received01/31/2007
Decision Date 07/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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