Freestyle Breastpump
The Medela Freestyle is a double electric breast pump for expressing and collecting milk from a lactating woman’s breasts. It applies cyclic negative pressure and can pump from one breast…
The Medela Freestyle is a double electric breast pump for expressing and collecting milk from a lactating woman’s breasts. It applies cyclic negative pressure and can pump from one breast or both breasts at the same time. It is intended for a single user.
The pump uses a motor-driven membrane mechanism and two-phase expression operation. A stimulation phase precedes the expression phase, and the user can adjust suction through nine settings. The display shows information such as the selected vacuum level and session duration.
Listed Item
Freestyle breast pump
Power and Portability
The Freestyle can run from its supplied power adapter or a removable rechargeable lithium-ion battery. Connecting the pump to the power supply automatically recharges the battery. The personal pump is intended for enclosed settings such as a home or office.
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 | Medela LLC, United States |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K150499 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Carton of 2, carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 67065 | 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 |
| Electric Breast Pump | Ningbo Huiyoo Baby Products 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 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253510 | 2026-04-10 |
| K253149 | 2026-02-13 |
| K253498 | 2026-01-22 |
| K251377 | 2025-09-18 |
| K232608 | 2024-04-12 |
| K210759 | 2021-08-11 |
| K200508 | 2020-06-15 |
| K191653 | 2019-10-17 |
| K181937 | 2018-10-16 |
| K161725 | 2016-10-28 |
| K151632 | 2015-11-05 |
| K150499 | 2015-04-21 |
| K053052 | 2006-05-02 |
| K031614 | 2003-06-06 |
| K020518 | 2002-03-07 |
| K950750 | 1995-10-16 |
| K901344 | 1990-08-06 |
| K875300 | 1988-04-06 |
| K801862 | 1980-10-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-10 | Not classified | Vendor change control | The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking nois | 11,154 units | 2012-05-21 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 2,030,390 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 1,293,304 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 581,296 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 3,019,835 kits | 2011-09-07 |
| 2010-03-15 | Not classified | Labeling Change Control | The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use. | 13,834 kits | 2010-12-10 |
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.