FDA 510(k) Application Details - K150436

Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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510(K) Number K150436
Device Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
No. 3 Building XiliBaimang Xusheng Industrial Estate
Nanshan
SHENZHEN 518108 CN
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Contact Jianping Kang
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Regulation Number 890.5860

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Classification Product Code IMG
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Date Received 02/19/2015
Decision Date 11/13/2015
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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