TPLC - Total Product Life Cycle

show TPLC since

Device	stimulator, transcutaneous electrical, aesthetic purposes
Product Code	NFO
Regulation Number	882.5890
Device Class	2

Premarket Reviews
Manufacturer	Decision
21 EQUIPMENT S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
AVAZZIA, INC
	SUBSTANTIALLY EQUIVALENT	1
BELEGA INC.
	SUBSTANTIALLY EQUIVALENT	1
BODY TRIM INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	1
CAROL COLE COMPANY DBA NUFACE
	SUBSTANTIALLY EQUIVALENT	3
CAROL COLE COMPANY DBA NUFACE®
	SUBSTANTIALLY EQUIVALENT	1
CAROLE COLE COMPANY
	SUBSTANTIALLY EQUIVALENT	1
FOREO INC.
	SUBSTANTIALLY EQUIVALENT	1
FOREO, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHARI DIGITAL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MICRO CURRENT TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
NSE PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
PREMIER NORTH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THERAGUN, INC.
	SUBSTANTIALLY EQUIVALENT	1
VUPIESSE S.R.L
	SUBSTANTIALLY EQUIVALENT	1
XTREEM PULSE
	SUBSTANTIALLY EQUIVALENT	1
XTREEM PULSE LLC
	SUBSTANTIALLY EQUIVALENT	1
XTREEM PULSE, LLC
	SUBSTANTIALLY EQUIVALENT	1
YA-MAN LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIIP, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Patient-Device Incompatibility	3	3
Patient Device Interaction Problem	2	2
Leak/Splash	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Off-Label Use	1	1
Output Problem	1	1
Device Markings/Labelling Problem	1	1
Material Discolored	1	1
Labelling, Instructions for Use or Training Problem	1	1
Unexpected Therapeutic Results	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Arrhythmia	5	5
Inflammation	4	4
Pain	4	4
Dizziness	3	3
Hemorrhage/Bleeding	3	3
Headache	3	3
Swelling	3	3
Increased Sensitivity	2	2
Nausea	2	2
Unspecified Tissue Injury	2	2
Rash	2	2
Burning Sensation	2	2
Dysphagia/ Odynophagia	2	2
Laceration(s)	2	2
Dyspnea	2	2
Swollen Lymph Nodes/Glands	1	1
Neuralgia	1	1
Low Blood Pressure/ Hypotension	1	1
Eye Pain	1	1
Loss of consciousness	1	1
Sore Throat	1	1
Deformity/ Disfigurement	1	1
Physical Asymmetry	1	1
Convulsion/Seizure	1	1
Blurred Vision	1	1
Tachycardia	1	1
Undesired Nerve Stimulation	1	1
Bradycardia	1	1
Hair Loss	1	1
Discomfort	1	1
Twitching	1	1
Retinal Detachment	1	1
Nerve Damage	1	1
Erythema	1	1
Neck Pain	1	1
No Known Impact Or Consequence To Patient	1	1
Skin Discoloration	1	1
Device Overstimulation of Tissue	1	1
Chemical Exposure	1	1
Local Reaction	1	1
Itching Sensation	1	1
Atrial Fibrillation	1	1
Malaise	1	1
Skin Inflammation/ Irritation	1	1
Presyncope	1	1
Fatigue	1	1
Hypersensitivity/Allergic reaction	1	1
Syncope/Fainting	1	1
Sleep Dysfunction	1	1