Ameda, Inc.
Ameda Pearl Electric Breast Pump with Hard Case and Cooler
40manufacturers in China registered for this device type
72catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Ameda, Inc., United States |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K950531 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment humidity 20 to 70 % RH; Handling environment temperature 53 to 93 °F; Storage environment humidity 20 to 90 % RH; Storage environment temperature -10 to 130 °F |
| Packaging | Outer carton of 10, outer carton, outer carton of 12, outer carton of 24, outer carton of 50, outer carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 17605 | In distribution | ||
| 17190 | 2 | In distribution | |
| 17243M | 40 | In distribution | |
| 17242M | In distribution | ||
| 17608 | In distribution | ||
| 17105 | In distribution | ||
| 17510LRT | In distribution | ||
| 17803R | In distribution | ||
| 10011 | In distribution | ||
| 201W23 | In distribution | ||
| 17803RT | In distribution | ||
| 17153 | In distribution | ||
| 17803LRTR | In distribution | ||
| 17243MT | In distribution | ||
| 10013 | In distribution | ||
| 17147M | 2 | In distribution | |
| 17608LRTR | In distribution | ||
| 17508RT | In distribution | ||
| 201W01H | In distribution | ||
| 10014 | In distribution | ||
| 17358M | In distribution | ||
| 10002 | 2 | In distribution | |
| 617802 | In distribution | ||
| 17146M | 2 | In distribution | |
| 17244M | In distribution | ||
| 17158 | In distribution | ||
| 10001 | 2 | In distribution | |
| 17803LRT | In distribution | ||
| 17003 | In distribution | ||
| 17212 | 2 | In distribution | |
| 17155 | In distribution | ||
| 201X10 | In distribution | ||
| 17187 | In distribution | ||
| 17186 | In distribution | ||
| 17245 | 150 | In distribution | |
| 201X13 | In distribution | ||
| 17156 | In distribution | ||
| 20001 | In distribution | ||
| 17071 | In distribution | ||
| 17150 | In distribution | ||
| 80001 | In distribution | ||
| 17803 | In distribution | ||
| 17188 | In distribution | ||
| 17112 | In distribution | ||
| 17152 | In distribution | ||
| 17084 | In distribution | ||
| 17803RTR | In distribution | ||
| 17170M | In distribution | ||
| 17070ACA | In distribution | ||
| 17076PM | In distribution | ||
| 17151 | In distribution | ||
| 17086 | In distribution | ||
| 617804 | In distribution | ||
| 201X09 | In distribution | ||
| 10010 | In distribution | ||
| 201X11 | In distribution | ||
| 17510RT | In distribution | ||
| 17603 | In distribution | ||
| 17085MT | In distribution | ||
| 17079M | In distribution | ||
| 10003 | 2 | In distribution | |
| 17083 | In distribution | ||
| 17450 | In distribution | ||
| 10004 | 2 | In distribution | |
| 201X12 | In distribution | ||
| 10012 | In distribution | ||
| 17085B | In distribution | ||
| 10005 | In distribution | ||
| 17148PM | In distribution | ||
| 30001 | In distribution | ||
| 17077MN | In distribution | ||
| 17115 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spectra | Uzinmedicare Co., Ltd. | 144 |
| Freemie | Dao Health | 93 |
| 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 |
|---|---|
| K221576 | 2022-10-12 |
| K203570 | 2021-04-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ameda, Inc. | 510(k) number | 2017-07-10 | Class III | Employee error | Two specific lots was incorrectly manufactured containing a UK power adapter. | 3,327 units total |
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.