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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve, peripheral, electric
Regulation Description Electrical peripheral nerve stimulator.
Product CodeKOI
Regulation Number 868.2775
Device Class 2


Premarket Reviews
ManufacturerDecision
IDMED
  SUBSTANTIALLY EQUIVALENT 1
MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 2
NERBIO MEDICAL SOFTWARE PLATFORMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SENZIME AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 1 1
2024 2 2
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Therapeutic Results 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Communication or Transmission Problem 1 1
Use of Device Problem 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Thermal Decomposition of Device 1 1
Gas Output Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Energy Output Problem 1 1
No Device Output 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Burn(s) 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

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