TPLC - Total Product Life Cycle

• 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
BIO-MEDICAL RESEARCH, LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOSONIC TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BODY TRIM INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	1
CAROL COLE COMPANY
	SUBSTANTIALLY EQUIVALENT	3
CAROL COLE COMPANY DBA NUFACE
	SUBSTANTIALLY EQUIVALENT	6
CAROLE COLE COMPANY
	SUBSTANTIALLY EQUIVALENT	1
DAKA INTERNATIONAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOREO, INC.
	SUBSTANTIALLY EQUIVALENT	1
HABALAN MED & BEAUTY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
HEAT IN A CLICK
	SUBSTANTIALLY EQUIVALENT	1
INFINITUS (CHINA) COMPANY LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOHARI DIGITAL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
JOHARI DIGITAL HEALTHCARE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LETO ENTERPRISE LTD.
	SUBSTANTIALLY EQUIVALENT	1
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MICRO CURRENT TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	4
NSE PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
NUSKIN
	SUBSTANTIALLY EQUIVALENT	1
NUTRA LUXE MD, LLC
	SUBSTANTIALLY EQUIVALENT	1
PAIN RELIEF TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PREMIER NORTH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
PRETIKA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAMA RESEARCH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
THERAGUN, INC.
	SUBSTANTIALLY EQUIVALENT	1
TROPHY SKIN, 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
ZIIP,LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	1	1
2016	5	5
2019	1	1
2020	6	6
2021	6	6
2022	5	5
2023	1	1
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10	10
Patient-Device Incompatibility	3	3
Insufficient Information	2	2
Patient Device Interaction Problem	2	2
Appropriate Term/Code Not Available	1	1
Device Markings/Labelling Problem	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Output Problem	1	1
Material Discolored	1	1
Labelling, Instructions for Use or Training Problem	1	1
Leak/Splash	1	1
Overheating of Device	1	1
Off-Label Use	1	1
Unexpected Therapeutic Results	1	1

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Ion Genius, Inc.	II	Mar-01-2012