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TPLC - Total Product Life Cycle
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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 CodeNGX
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 17
Insufficient Information 5 5
Overheating of Device 4 4
No Apparent Adverse Event 3 4
Leak/Splash 2 2
Crack 2 2
Unintended Electrical Shock 2 2
Patient-Device Incompatibility 2 2
Use of Device Problem 2 2
Structural Problem 2 2
Product Quality Problem 2 2
Delayed Charge Time 2 2
Unintended Power Up 1 1
Device Markings/Labelling Problem 1 1
Smoking 1 2
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Lack of Effect 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 9
Full thickness (Third Degree) Burn 4 4
Urticaria 3 3
Electric Shock 3 3
Unspecified Musculoskeletal problem 3 3
Burn(s) 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Muscle Weakness 2 2
Itching Sensation 2 2
Insufficient Information 2 2
Erythema 2 2
Undesired Nerve Stimulation 2 2
Partial thickness (Second Degree) Burn 2 2
Menstrual Irregularities 1 5
Superficial (First Degree) Burn 1 1
Abdominal Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Inflammation/ Irritation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blister 1 1
Rupture 1 1
Burning Sensation 1 1
Hernia 1 1
Discomfort 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Nodule 1 1
Intervertebral Disc Compression or Protrusion 1 1
Tinnitus 1 1
Hot Flashes/Flushes 1 5
Inadequate Pain Relief 1 1

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