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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electro-acupuncture
Product CodeBWK
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BIEGLER GMBH
  SUBSTANTIALLY EQUIVALENT 2
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
DYANSYS INC
  SUBSTANTIALLY EQUIVALENT 1
DYANSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNO-HEALTH TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LHASA OMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEVICE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NAVIGANT CONSULTING, INC.
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO.
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1 1
2023 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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