|
Device |
stimulator, electrical, non-implantable, for incontinence |
Product Code | KPI |
Regulation Number |
876.5320
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCELERATED CARE PLUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJI DYNAMICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INCONTROL MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
5
|
INCONTROL MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INMODE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERNATIONAL TRADE GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANJING VISHEE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIENTAL INSPIRATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN KONMED TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN KONMED TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MED-LINK ELECTRONICS TECH CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TENSCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TENSCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
THOUGHT TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERITY SCIENTIFIC LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL-LIFE HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER MEDIZINSYSTEME GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZMI ELECTRONICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYNEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|