FDA 510(k) Application Details - K242787

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

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510(K) Number K242787
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Changsha Anxiang Medical Technology Co., LTD
Room 2404, Kairui Building,No. 245 Laodong West Road,
Tianxin District
Changsha 410007 CN
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Contact William Fu
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 09/16/2024
Decision Date 12/18/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242787


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