Electric Breast Pump
The BLA8015-02 Electric Breast Pump expresses and collects breast milk using a software-controlled vacuum pump. It provides single pumping for one user and can be reused by that user. The…
The BLA8015-02 Electric Breast Pump expresses and collects breast milk using a software-controlled vacuum pump. It provides single pumping for one user and can be reused by that user. The pump is powered by a lithium-ion battery and is intended for hospital or home use.
Four operating modes are available: massage, continuous expression, frequency conversion and normal expression. Massage and continuous modes offer six levels, while the other two offer nine. Users adjust suction from 20 to 240 mmHg with mode and level controls shown on an LCD.
Pumping Cycle
During a cycle, the vacuum pump removes air from the pumping cavity until the selected suction is reached. Expressed milk then opens a valve and flows into the collection bottle through the pressure difference. The device starts in massage mode at level one and is supplied nonsterile.
Who Else Makes It
Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Joytech Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 6 |
| Jiangsu Xinbei Electrical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Huizhou LVB Maternal AND Infant Supplies Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Huizhou Sunwinon Electronics Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Mastars Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Rrdonnelley | Dongguan | Guangdong | Contract manufacturer | 3 |
| SFY Intelligent Technology (Suzhou) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered
Record
| Listed by | Ningbo Huiyoo Baby Products Co., Ltd., China |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Manufacturer |
| 510(k) | K191802 |
| Record published | 2020-02-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BLA8038 | In distribution | ||
| BLA8043 | In distribution | ||
| BLA8037 | In distribution | ||
| RBX8020 | In distribution | ||
| BLA8021 | In distribution | ||
| BLA8019 | In distribution | ||
| BLA8020 | In distribution | ||
| BLA8041 | In distribution | ||
| RBX8037 | In distribution | ||
| RBX8030 | In distribution | ||
| BLA8042-2 | 2 | In distribution | |
| BLA8024 | In distribution | ||
| BLA-8015-02 | In distribution | ||
| RBX8015 | In distribution | ||
| BLA8023 | In distribution | ||
| BLA8042 | In distribution | ||
| BLA8035 | In distribution | ||
| BLA8034 | In distribution | ||
| BLA8015-02 | In distribution | ||
| BLA8040 | In distribution | ||
| BLA8040-2 | In distribution | ||
| RBX8028 | In distribution | ||
| BLA8022 | In distribution | ||
| RBX8029 | In distribution | ||
| BLA-8015 | In distribution | ||
| RBX8031 | In distribution | ||
| BLA8039 | In distribution | ||
| RBX8021 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spectra | Uzinmedicare Co., Ltd. | 144 |
| Freemie | Dao Health | 93 |
| Ameda, Inc. | Ameda, Inc. | 72 |
| Motif Medical | Cimilre Co., Ltd. | 47 |
| Momcozy | Shenzhen Root Innovation Technology Co., Ltd. | 44 |
| Symmetrical Health, LLC | Cimilre Co., Ltd. | 28 |
| Ameda® | Cimilre Co., Ltd. | 22 |
| LVB | Huizhou LVB Maternal & Infant Supplies Co., Ltd. | 17 |
| Vive | Vive Health LLC | 17 |
| ViveCare | Vive Health LLC | 16 |
| Stella Baby USA | Cimilre Co., Ltd. | 15 |
| Unimom | Unimom Co. | 15 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191802 | 2020-01-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.