|
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
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Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A-1 ENGINEERING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACTEGY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
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
|
1
|
BIO-MEDICAL RESEARCH LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
1
|
DONGGUAN YINGFENG METAL & PLASTIC PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EL.EN. S.P.A. |
|
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
|
4
|
HEAT IN A CLICK LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEBEI JT MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIVOX BIOTEK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I-MOTION GROUP GLOBAL IBERICA S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHARI DIGITAL HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K1MED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KATALYST INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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 OSTO TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOFWAVE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYECE LTD. |
|
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
|
ZIMMER MEDIZINSYSTEME GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
BEMER INT. AG |
II |
Feb-10-2021 |
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