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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, transcutaneous, over-the-counter
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Product CodeNUH
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
CHATTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
Well-Life Healthcare Limited
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No Information 7
No Known Device Problem 4
Output issue 1
Torn material 1
Overheating of device or device component 1
Human-Device Interface Issue 1
Total Device Problems 15

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