|
|
| 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
|
|
1. K222528 Well-Life Probe Electrode for Stimulation/EMG Prob ...
|
| ZIMMER MEDIZINSYSTEME GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZMI ELECTRONICS LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZYNEX MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
