Freemie
Freemie Deluxe Collection System/Asia Pacific
40manufacturers in China registered for this device type
93catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Dao Health, United States |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| 510(k) | K130349 |
| Record published | 2021-11-20 |
| Record revised | 2021-08-31 (version 4) |
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 |
| Packaging | Case of 100, case of 12, case of 6, case of 250 |
| Distribution end date | 2021-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG107 | In distribution | |
| FG099 | In distribution | |
| FG097 | In distribution | |
| FG120 | In distribution | |
| FG068 | In distribution | |
| FG124 | In distribution | |
| FG106 | In distribution | |
| FG086 | In distribution | |
| FG098 | In distribution | |
| FG065 | In distribution | |
| FG089 | In distribution | |
| FG062 | In distribution | |
| FG075 | In distribution | |
| FG072 | In distribution | |
| FG095 | In distribution | |
| FG085 | In distribution | |
| FG101 | In distribution | |
| FG126 | In distribution | |
| FG108 | In distribution | |
| FG109 | In distribution | |
| FG073 | In distribution | |
| FG064 | In distribution | |
| FG091 | In distribution | |
| FG100 | In distribution | |
| FG092 | In distribution | |
| FG111 | In distribution | |
| FG110 | In distribution | |
| FG104 | In distribution | |
| FG117 | In distribution | |
| FG112 | In distribution | |
| FG113 | In distribution | |
| FG063 | In distribution | |
| FG066 | In distribution | |
| FG123 | In distribution | |
| FG074 | In distribution | |
| FG070 | In distribution | |
| FG093 | In distribution | |
| FG069 | In distribution | |
| FG088 | In distribution | |
| FG087 | In distribution | |
| FG096 | In distribution | |
| FG118 | In distribution | |
| FG080 | In distribution | |
| FG079 | In distribution | |
| FG071 | In distribution | |
| FG121 | In distribution | |
| FG119 | In distribution | |
| FG094 | In distribution | |
| FG116 | In distribution | |
| FG090 | In distribution | |
| FG067 | In distribution | |
| FG114 | In distribution | |
| FG076 | In distribution | |
| FG077 | In distribution | |
| FG102 | In distribution | |
| FG083 | In distribution | |
| FG081 | In distribution | |
| FG115 | In distribution | |
| FG125 | In distribution | |
| FG105 | In distribution | |
| FG084 | In distribution | |
| FG122 | In distribution | |
| FG045 | Withdrawn | |
| FG049 | Withdrawn | |
| FG050 | Withdrawn | |
| FG027 | Withdrawn | |
| FG026 | Withdrawn | |
| FG061 | Withdrawn | |
| FG052 | Withdrawn | |
| FG021 | Withdrawn | |
| FG058 | Withdrawn | |
| FG054 | Withdrawn | |
| FG056 | Withdrawn | |
| FG048 | Withdrawn | |
| FG060 | Withdrawn | |
| FG057 | Withdrawn | |
| FG053 | Withdrawn | |
| FG022 | Withdrawn | |
| FG041 | Withdrawn | |
| FG030 | Withdrawn | |
| FG051 | Withdrawn | |
| FG046 | Withdrawn | |
| FG032 | Withdrawn | |
| FG047 | Withdrawn | |
| FG023 | Withdrawn | |
| FG059 | Withdrawn | |
| FG020 | Withdrawn | |
| FG044 | Withdrawn | |
| FG043 | Withdrawn | |
| FG025 | Withdrawn | |
| FG055 | Withdrawn | |
| FG024 | Withdrawn | |
| FG029 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spectra | Uzinmedicare Co., Ltd. | 144 |
| 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 |
| Unimom | Unimom Co. | 15 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172772 | 2017-10-13 |
| K130349 | 2013-09-06 |
| K111411 | 2012-02-01 |
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.