TPLC - Total Product Life Cycle

• Device: stimulator, muscle, powered, for muscle conditioning
• Definition: A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
• Product Code: NGX
• Regulation Number: 890.5850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
A-1 ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
ACTEGY, LTD.
	SUBSTANTIALLY EQUIVALENT	4
AIME MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AK BEAUTY ENTERPRISES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARRIVE SYSTEMS INC
	SUBSTANTIALLY EQUIVALENT	1
AURA WELLNESS, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ADSS DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEMER INT AG
	SUBSTANTIALLY EQUIVALENT	1
BEMER INT. AG
	SUBSTANTIALLY EQUIVALENT	2
BIO-MEDICAL RESEARCH LTD
	SUBSTANTIALLY EQUIVALENT	2
BIO-MEDICAL RESEARCH LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BTL
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
CASGARUM INVESTMENT, S.L.
	SUBSTANTIALLY EQUIVALENT	1
CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CREATIVE FITNESS DEVELOPMENTS S.L.
	SUBSTANTIALLY EQUIVALENT	1
DJO, LLC
	SUBSTANTIALLY EQUIVALENT	3
DK ELECTRONICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN YINGFENG METAL & PLASTIC PRODUCTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
EL.EN. S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EVERYWAY MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FAST FIT LLC
	SUBSTANTIALLY EQUIVALENT	1
FIRSTKIND LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIT-PRO LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU XINBO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HEAT IN A CLICK LLC.
	SUBSTANTIALLY EQUIVALENT	1
HIVOX BIOTEK INC.
	SUBSTANTIALLY EQUIVALENT	1
HOME SKINOVATIONS LTD.
	SUBSTANTIALLY EQUIVALENT	1
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
I-MOTION GROUP GLOBAL IBERICA S.L.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL TRADE GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHARI DIGITAL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	2
K1MED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KATALYST INC.
	SUBSTANTIALLY EQUIVALENT	3
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL CABLES S.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL CABLES, S.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL CURRENTS LTD
	SUBSTANTIALLY EQUIVALENT	1
MIHA BODYTEC GMBH
	SUBSTANTIALLY EQUIVALENT	3
NANJING VISHEE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEURO20 TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
NEUX TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN, LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HENGBOSI INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN KELUTONGDA INDUSTRIAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SMARTMISSIMO TECHNOLOGIES PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
TYECE LTD.
	SUBSTANTIALLY EQUIVALENT	2
VB TECHNOLOGIES AG
	SUBSTANTIALLY EQUIVALENT	1
WELL BRAIN INTERNATIONAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
XBODY HUNGARY KFT.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN COMFIER TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2016	21	21
2017	2	2
2018	6	6
2019	4	4
2020	7	7
2021	5	5
2022	7	7
2023	8	8
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22	22
Insufficient Information	11	11
Patient-Device Incompatibility	4	4
Improper or Incorrect Procedure or Method	3	3
Overheating of Device	3	3
No Apparent Adverse Event	3	3
Use of Device Problem	2	2
Unintended Electrical Shock	2	2
Fire	2	2
Electrical Shorting	2	2
Failure to Auto Stop	1	1
Device Operates Differently Than Expected	1	1
Leak/Splash	1	1
Melted	1	1
Structural Problem	1	1
Defective Device	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Smoking	1	1
Thermal Decomposition of Device	1	1
Failure to Conduct	1	1
Corroded	1	1
Electromagnetic Interference	1	1
Patient Device Interaction Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	6	6
Rash	4	4
Hernia	4	4
Full thickness (Third Degree) Burn	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Electric Shock	3	3
Superficial (First Degree) Burn	3	3
Chest Pain	3	3
Dyspnea	2	2
Hypersensitivity/Allergic reaction	2	2
Itching Sensation	2	2
Bone Fracture(s)	2	2
Muscle Weakness	2	2
Seizures	2	2
Tachycardia	2	2
Therapeutic Effects, Unexpected	1	1
Thrombosis	1	1
Tinnitus	1	1
Hot Flashes/Flushes	1	1
Tingling	1	1
Cramp(s)	1	1
No Consequences Or Impact To Patient	1	1
Brain Injury	1	1
Swelling	1	1
Retinal Detachment	1	1
Wheal(s)	1	1
Urticaria	1	1
Anxiety	1	1
Palpitations	1	1
Undesired Nerve Stimulation	1	1
Neuropathy	1	1
Hemorrhage, Cerebral	1	1
Menstrual Irregularities	1	1
Muscle Spasm(s)	1	1
Non specific EKG/ECG Changes	1	1
Electro-Mechanical Dissociation	1	1
Cyst(s)	1	1
Muscle Stimulation	1	1
Arrhythmia	1	1
Burn(s)	1	1
Cardiac Arrest	1	1
Partial thickness (Second Degree) Burn	1	1
No Patient Involvement	1	1
Heavier Menses	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Unspecified Musculoskeletal problem	1	1
Nodule	1	1
Swelling/ Edema	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BEMER INT. AG	II	Feb-10-2021