FDA 510(k) Application Details - K222669

Device Classification Name Massager, Powered Inflatable Tube

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510(K) Number K222669
Device Name Massager, Powered Inflatable Tube
Applicant Chengdu Cryo-Push Medical Technology Co., Ltd
102, 105, Zone 20, Huayin Industrial Port, No. 618
Kexing Road (West), Wenjiang District
Chengdu 611137 CN
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Contact Zhang Peiyong
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Regulation Number 890.5650

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Classification Product Code IRP
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Date Received 09/06/2022
Decision Date 12/05/2022
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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