TPLC - Total Product Life Cycle

show TPLC since

Device	stimulator, nerve, peripheral, electric
Regulation Description	Electrical peripheral nerve stimulator.
Product Code	KOI
Regulation Number	868.2775
Device Class	2

Premarket Reviews
Manufacturer	Decision
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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2	2
Unexpected Therapeutic Results	2	2
Signal Artifact/Noise	1	1
Material Split, Cut or Torn	1	1
Break	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Energy Output Problem	1	1
Insufficient Information	1	1
Erratic Results	1	1
Material Integrity Problem	1	1
No Audible Alarm	1	1
Alarm Not Visible	1	1
Patient Device Interaction Problem	1	1
Use of Device Problem	1	1
Thermal Decomposition of Device	1	1
Device Handling Problem	1	1
Protective Measures Problem	1	1
Overheating of Device	1	1
Gas Output Problem	1	1
No Device Output	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
Unspecified Tissue Injury	1	1
Partial thickness (Second Degree) Burn	1	1