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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, counter-pulsating, external
Product CodeDRN
Regulation Number 870.5225
Device Class 2


Premarket Reviews
ManufacturerDecision
CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CIRCULATOR BOOT CORP.
  SUBSTANTIALLY EQUIVALENT 1
OMAY(GUANGZHOU)MED TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STAGE 2 INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
VAMED MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VAMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XTREEM PULSE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiomedics Incorporated II Jul-07-2009
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