FDA 510(k) Application Details - K071320

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K071320
Device Name Stimulator, Muscle, Powered
Applicant EVERLIFE MEDICAL EQUIPMENT CO., LTD.
NO. 58, FU-CHIUN STREET
HSIN CHU CITY 30067 TW
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Contact JEN KE-MIN
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 05/10/2007
Decision Date 08/17/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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