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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device stimulator, electro-acupuncture
Product CodeBWK
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LHASA OMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stroke/CVA 1 1
Insufficient Information 1 1

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