FDA 510(k) Application Details - K230024

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

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510(K) Number K230024
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Beijing Sano Laser S&T Development Co., Ltd
Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi
District
Bejing 010-57150601 CN
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Contact Hongbo Zhang
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 01/04/2023
Decision Date 09/06/2023
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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