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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-implanted nerve stimulator for pain associated with irritable bowel syndrome (ibs)
Definition A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.
Product CodeQHH
Regulation Number 876.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
DYANSYS, INC
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH SOLUTIONS (IHS), INC.
  GRANTED 1
TRANSTIMULATION RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 2 2
Pain 2 2
Dizziness 2 2

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