|
Device |
vehicle, motorized 3-wheeled |
Product Code | INI |
Regulation Number |
890.3800
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVANCED VEHICLE CONCEPTS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AFIKIM ELECTRIC VEHICLES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AGILE DISTRIBUTORS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMIGO MOBILITY INTL., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI JBH MEDICAL APPARATUS CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BESTEAM TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.T.M. HOMECARE PRODUCT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CHIEN TI ENTERPRISE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DONGGUAN PRESTIGE SPORTING GOODS., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EUROGREEN INTERNATIONAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EUROGREEN INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FREERIDER CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FREERIDER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FREERIDER LUGGIE SCOOTERS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
1. K092154 HEARTWAY POWER MOBILITY SCOOTER, S9
|
2. K092155 HEARTWAY POWER MOBILITY SCOOTER, S8
|
3. K092650 HEARTWAY POWER MOBILITY SCOOTER, S12
|
4. K101142 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
|
5. K101143 HEARTWAY POWER MOBILITY SCOOTER, S11
|
6. K132855 HEARTWAY POWER MOBILITY SCOOTER
|
7. K150987 HEARTWAY Power Mobility Scooter, BRIO S19
|
8. K150998 HEARTWAY Power Mobility Scooter
|
9. K151656 HEARTWAY Power Mobility Scooter
|
10. K220227 Auto Folding Scooter, S21F
|
KWANG YANG MOTOR CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LETRIX POWER HANGZHOU PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERITS HEALTH PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MOVING LIFE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRESTIGE SPORTING GOODS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRIDE MOBILITY PRODUCTS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PUC PERFECT UNION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNTECH UK LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SVRC INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TZORA ACTIVE SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WU'S TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WU’S TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YONGKANG YILE VEHICLE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
|
|
|