FDA 510(k) Application Details - K202648

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K202648
Device Name Stimulator, Muscle, Powered
Applicant Shenzhen Konmed Technology Co., Ltd.
601, Building B4,
Shenchengtou Creative Factory Life Science Park
Shenzhen 518118 CN
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Contact Tony No Last Name Provided
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 09/11/2020
Decision Date 12/08/2020
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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