|
Device |
pump, breast, powered |
Product Code | HGX |
Regulation Number |
884.5160
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A CUTE BABY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUTE IDEAS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMEDA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANNABELLA LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANNABELLA TECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AOJ HEALTH TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARDO MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BABYATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BISTOS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLUE EGG CO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIARO TECHNOLOGY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CIMILRE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CIXI RUIHONG ELECTRIC APPLIANCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DAO HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEVON MEDICAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN RONGFENG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUANSHI YIYINGMEI TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENKO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVENFLO COMPANY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EVENFLO FEEDING INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVENFLO FEEDING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXPLORAMED NC7, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXPLORAMED NC7, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENADYNE BIOTECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GLOBALCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU JINXINBAO ELECTRONIC CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU YONGYI INDUSTRIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HAENIM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HYGEIA II MEDICAL GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
HYGEIA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMANI CO. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOYTECH HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANSINOH LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMERICK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUV N' CARE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAPA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAYBORN (UK) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAYBORN GROUP LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDEL S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDELA AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDELA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDELA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MILKMATE PRODUCTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MILKMATE PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOXXLY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANTONG POLY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAYA HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO DEAREVERY ELECTRONIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO HUIYOO BABY PRODUCTS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS CONSUMER LIFESTYLE - INNOVATION SITE EINDHOVEN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS CONSUMER LIFESTYLE-INNOVATION SITE EINDHOVEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN TPH TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN TPH TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMPLISSE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOMY INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNIMOM CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNIMOM.CO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UZINMEDICARE CO. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
UZINMEDICARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UZINMEDICARE COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILLOW INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WUXI XINZHONGRUI BABY SUPPLIES CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X6 INNOVATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CAREBAO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|