FDA 510(k) Application Details - K070299

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K070299
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EZFIT TECHNOLOGY INC.
NO.42, SECTION 3, CHANG SHI RD
AN NAN DISTRICT
TAINAN CITY 709 TW
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Contact OU YANG
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/31/2007
Decision Date 07/16/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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