|
Device |
wheelchair, mechanical |
Regulation Description |
Mechanical wheelchair. |
Product Code | IOR |
Regulation Number |
890.3850
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
BOWHEAD DESIGN CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KI MOBILITY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LICHTMEGA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHERA AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POWER PLUS MOBILITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RGK WHEELCHAIRS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROUGHRIDER AMERICA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN AST MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN AST MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TURBO WHEELCHAIR CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
TiSport, Llc |
II |
Nov-18-2021 |
|
|
|
|