FDA 510(k) Application Details - K222875

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K222875
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Nanjing Vishee Medical Technology Co., Ltd.
Building 9, No. 19, Ningshuang Road
Yuhuatai District
Nanjing 210012 CN
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Contact Kai QIU
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 09/22/2022
Decision Date 03/09/2023
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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