TPLC - Total Product Life Cycle

• Device: stimulator, muscle, powered, for muscle conditioning
• Regulation Description: Powered muscle stimulator.
• 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
ACTEGY , LTD.
	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	2
BIO-MEDICAL RESEARCH, LTD.
	SUBSTANTIALLY EQUIVALENT	1
BTL
	SUBSTANTIALLY EQUIVALENT	1
CHANGSHA ANXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CPMT LASER (CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
CREATIVE FITNESS DEVELOPMENTS S.L.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EYWA SRL
	SUBSTANTIALLY EQUIVALENT	1
FIT-PRO , LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU LONGEST MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU XINBO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
HEBEI JT MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
I-MOTION GROUP GLOBAL IBERICA S.L.
	SUBSTANTIALLY EQUIVALENT	1
JOHARI DIGITAL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
K1MED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL CABLES S.L.
	SUBSTANTIALLY EQUIVALENT	1
MIHA BODYTEC GMBH
	SUBSTANTIALLY EQUIVALENT	2
MOTIVE HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANJING VISHEE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEURO20 TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
OFAN INTELLIGENT TECHNOLOGY (GUANGZHOU) CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
PEPPER INTERACTIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HENGBOSI INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN KELUTONGDA INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOFWAVE MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	3
SYRMA JOHARI MEDTECH LIMITED
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD S.L.
	SUBSTANTIALLY EQUIVALENT	1
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
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	4

MDR Year	MDR Reports	MDR Events
2021	5	9
2022	7	8
2023	8	8
2024	11	11
2025	15	15
2026	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Insufficient Device Problem Information	5	5
Overheating of Device	4	4
Leak/Splash	4	4
No Apparent Adverse Event	3	4
Structural Problem	2	2
Crack	2	2
Unintended Electrical Shock	2	2
Patient-Device Incompatibility	1	1
Use of Device Problem	1	1
Smoking	1	2
Delayed Charge Time	1	1
Improper or Incorrect Procedure or Method	1	1
Unintended Power Up	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10	11
Full thickness (Third Degree) Burn	4	4
Electric Shock	3	3
Burn(s)	3	3
Pain	3	3
Unspecified Musculoskeletal problem	3	3
Urticaria	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Muscle Weakness/Atrophy	2	2
Erythema	2	2
Caustic/Chemical Burns	2	2
Itching Sensation	2	2
Partial thickness (Second Degree) Burn	2	2
Undesired Nerve Stimulation	2	2
Insufficient Information	2	2
Abdominal Pain	1	1
Skin Inflammation/ Irritation	1	1
Tachycardia	1	1
Discomfort	1	1
Menstrual Irregularities	1	5
Hypersensitivity/Allergic reaction	1	1
Superficial (First Degree) Burn	1	1
Rupture	1	1
Hot Flashes/Flushes	1	5
Swelling/ Edema	1	1
Burning Sensation	1	1
Blister	1	1
Pelvic Pain	1	1
Intervertebral Disc Compression or Protrusion	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Hernia	1	1
Tinnitus	1	1
Nodule	1	1
Inadequate Pain Relief	1	1

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