Spectra
The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with…
The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them.
40manufacturers in China registered for this device type
144catalogue numbers in this listing
12510(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 | Uzinmedicare Co., Ltd., South Korea |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K210124 |
| Record published | 2026-02-03 |
| Record revised | 2024-09-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 95 % RH; Storage environment humidity 20 to 95 % RH; Handling environment temperature 5 to 40 °C; Storage environment temperature -20 to 50 °C |
| Packaging | Carton box of 2, carton box of 50, carton box of 48, carton box of 200, design box, carton box of 250 |
| Sizes | Lumen/inner diameter 20 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Spectra accessory kit(32mm shield set) | In distribution | ||
| Spectra accessory kit(20mm shield set) | In distribution | ||
| SG Premium Accessory Kit (24mm) | In distribution | ||
| Spectra SG gold portable | In distribution | ||
| Spectra Wearable | In distribution | ||
| Spectra S1 Plus | In distribution | ||
| Spectra SG Portable | In distribution | ||
| Spectra Wearable Accessory (backflow protector) | In distribution | ||
| Spectra accessory (cooler kit) | In distribution | ||
| Spectra 9 Plus | In distribution | ||
| Spectra breast shield kit(24mm) | In distribution | ||
| Spectra SG Portable_cara cup | In distribution | ||
| Spectra S1 plus | In distribution | ||
| Spectra S1 Plus | In distribution | ||
| Spectra accessory (backflow protector) | In distribution | ||
| Spectra 9 Plus | In distribution | ||
| Spectra accessory (20mm shield set) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra accessory (24mm shield set) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra accessory (SG Portable Bagic Accessory Kit) | In distribution | ||
| Spectra 9plus_cara cup | In distribution | ||
| Spectra SG Portable_cara cup(28mm set) | In distribution | ||
| Spectra accessory (24mm shield set) | Lumen/Inner Diameter 24 mm | In distribution | |
| 9 Plus baisic accessory kit (CaraCups 24mm) | In distribution | ||
| sg portable basic accessories kit (24mm/28mm) | In distribution | ||
| Spectra S3 Pro | In distribution | ||
| Spectra series (milk collection) | 30 | In distribution | |
| Spectra accessory kit(28mm shield set) | In distribution | ||
| Spectra S2 Plus | In distribution | ||
| Spectra accessory(20mm Breast shield) | Lumen/Inner Diameter 20 mm | 250 | In distribution |
| Spectra S3 Pro | In distribution | ||
| Milk storage bottles (All set) | 2 | In distribution | |
| Spectra Accessory (16mm Breast Shield Set) | In distribution | ||
| Spectra accessory (Accessory Kit for S1&S2 ( 24mm )) | In distribution | ||
| Spectra Wearable Accessory (valve, backflow protector) | In distribution | ||
| Spectra S2 Plus | In distribution | ||
| Spectra S2 plus | In distribution | ||
| Spectra S3 Pro | In distribution | ||
| Spectra accessory (28mm Care Cup) | Lumen/Inner Diameter 28 mm | In distribution | |
| Spectra breast shield kit(20mm) | In distribution | ||
| Spectra accessory (cooler kit) | In distribution | ||
| Spectra accessory(24mm Breast shield) | Lumen/Inner Diameter 24 mm | 4 | In distribution |
| Spectra S3 Pro | In distribution | ||
| Cooler Kit | In distribution | ||
| Spectra accessory (28mm shield set) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra accessory(small cap) | In distribution | ||
| Spectra accessory(hose tip) | In distribution | ||
| sg basic accessories kit (24mm/28mm) | In distribution | ||
| Breast milk storage bottle package | In distribution | ||
| Spectra Wearable Accessory (valve) | In distribution | ||
| Spectra accessory (Accessory Kit for SG Premium(28mm)) | In distribution | ||
| Spectra accessory (CaraCups Backflow Protector Replacement Kit) | 2 | In distribution | |
| Spectra accessory kit(20mm shield set) | In distribution | ||
| Spectra SG Portable_cara cup | In distribution | ||
| Spectra 9 Plus (with CaraCups) | In distribution | ||
| Spectra Synergy Gold | In distribution | ||
| Spectra accessory(Silicone head set) | 2 | In distribution | |
| Spectra Wearable | In distribution | ||
| Spectra breast shield kit(32mm) | In distribution | ||
| 96PK Milk Storage Bottles | 96 | In distribution | |
| Spectra accessory(32mm Breast shield) | Lumen/Inner Diameter 32 mm | In distribution | |
| Spectra Wearable Accessory (valve) | In distribution | ||
| Spectra Synergy Gold | In distribution | ||
| Spectra breast shield kit(16mm) | In distribution | ||
| Spectra accessory(20mm shield set) | Lumen/Inner Diameter 20 mm | In distribution | |
| Spectra PP bottle set | In distribution | ||
| Spectra accessory (Accessory Kit for S1&S2 ( 28mm )) | In distribution | ||
| SG Premium Accessory Kit (20mm) | In distribution | ||
| Milk storage bottles | 2 | In distribution | |
| Spectra SG gold portable | In distribution | ||
| Spectra series (milk collection bag-connector) | 10 | In distribution | |
| Spectra accessory (Bagic Accessory Kit (24mm/28mm)) | In distribution | ||
| Cooler Kit | In distribution | ||
| Spectra accessory (28mm Breast shield) | Lumen/Inner Diameter 28 mm | 4 | In distribution |
| Spectra 9 Plus | In distribution | ||
| Spectra Wearable | In distribution | ||
| Spectra accessory (S1/S2/S3 Bagic Accessory Kit) | In distribution | ||
| Spectra accessory kit(24mm shield set) | In distribution | ||
| Spectra accessory kit(24mm shield set) | In distribution | ||
| Spectra accessory (SG Tubing Connector) | 2 | In distribution | |
| Spectra Wearable power adapter | In distribution | ||
| Spectra accessory (Silicone massager) | In distribution | ||
| Spectra series (milk Bag) | 30 | In distribution | |
| Spectra accessory kit(24mm shield set) | In distribution | ||
| Spectra accessory (28mm Breast shield) | Lumen/Inner Diameter 28 mm | In distribution | |
| Spectra accessory (Brest Shield (28mm) 2ea) | 2 | In distribution | |
| Spectra Wearable Accessory (backflow protector) | In distribution | ||
| Spectra accessory(Duckbill Valve for Cara Cup) | 2 | In distribution | |
| Spectra accessory(air hose) | In distribution | ||
| Spectra accessory(32mm Breast shield) | Lumen/Inner Diameter 32 mm | 250 | In distribution |
| Spectra accessory kit(24mm shield set) | In distribution | ||
| 9 Plus accessory (CaraCups Flange 28mm) | In distribution | ||
| Spectra accessory (Bagic Accessory Kit (24mm)) | In distribution | ||
| Spectra series (milk Bag) | 90 | In distribution | |
| Spectra accessory kit(32mm shield set) | In distribution | ||
| Spectra accessory kit(20mm shield set) | In distribution | ||
| Spectra accessory kit(28mm shield set) | In distribution | ||
| Spectra S1 plus | In distribution | ||
| Spectra accessory (Accessory Kit for Dew350) | In distribution | ||
| Spectra Synergy Gold | In distribution | ||
| Spectra accessory (small cap) | 2 | In distribution | |
| Spectra accessory(air hose) | In distribution | ||
| Spectra Synergy Gold | In distribution | ||
| Spectra accessory (Bottle Set) | 2 | In distribution | |
| SG Premium Accessory Kit (28mm) | In distribution | ||
| Spectra Wearable Accessory kit | In distribution | ||
| Spectra 9 Plus | In distribution | ||
| Spectra accessory(CaraCups Duckbill Valve Replacement Kit) | 2 | In distribution | |
| Spectra S2 plus | In distribution | ||
| Spectra Wearable power adapter | In distribution | ||
| Spectra accessory (Head+Membrane) | 2 | In distribution | |
| Spectra SG Portable | In distribution | ||
| Spectra 9 Plus | In distribution | ||
| Spectra accessory (Cara Cup Backflow Cap) | 2 | In distribution | |
| Spectra accessory (28mm Breast shield) | Lumen/Inner Diameter 28 mm | 250 | In distribution |
| Spectra accessory (Accessory Kit for SG Premium(24mm)) | In distribution | ||
| Spectra accessory(20mm Breast shield) | Lumen/Inner Diameter 20 mm | 4 | In distribution |
| Spectra SG Portable_cara cup(24mm set) | In distribution | ||
| Breast milk storage bottle package | In distribution | ||
| Spectra accessory (28mm Breast shield) | Lumen/Inner Diameter 28 mm | 250 | In distribution |
| Spectra accessory (Cara Cup Backflow Protector Kit) | 2 | In distribution | |
| Spectra accessory (SG Tubing) | 2 | In distribution | |
| Spectra Wearable power adapter plug | In distribution | ||
| Spectra accessory (Accessory Kit for S1&S2 ( 32mm )) | In distribution | ||
| Spectra PP bottle set | In distribution | ||
| Spectra accessory(24mm Breast shield) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra accessory(20mm Breast shield) | Lumen/Inner Diameter 20 mm | In distribution | |
| Spectra accessory (24mm Cara Cup) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra breast shield kit(28mm) | In distribution | ||
| Spectra accessory (16mm Breast Shield) | In distribution | ||
| Spectra accessory(32mm shield set) | Lumen/Inner Diameter 32 mm | In distribution | |
| Spectra accessory (tubing) | In distribution | ||
| Spectra 9 Plus_cara cup | In distribution | ||
| Spectra accessory (SG Bagic Accessory Kit) | In distribution | ||
| Spectra accessory (28mm shield set) | Lumen/Inner Diameter 28 mm | In distribution | |
| Spectra accessory (32mm shield set) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra accessory(16mm Breast shield) | Lumen/Inner Diameter 24 mm | In distribution | |
| Spectra Wearable power adapter plug | In distribution | ||
| Spectra accessory (DEW350 Bagic Accessory Kit) | In distribution | ||
| Spectra DEW350 | In distribution | ||
| Spectra accessory(32mm Breast shield) | Lumen/Inner Diameter 32 mm | 4 | In distribution |
| 96PK Milk Storage Bottles | In distribution | ||
| Spectra accessory(24mm Breast shield) | Lumen/Inner Diameter 24 mm | 250 | In distribution |
| Spectra accessory (9Plus Bagic Accessory Kit) | In distribution | ||
| Spectra accessory (Accessory Kit for S1&S2 ( 20mm )) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Unimom | Unimom Co. | 15 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260956 | 2026-06-04 |
| K250208 | 2026-04-06 |
| K251423 | 2026-02-06 |
| K251932 | 2025-11-25 |
| K220926 | 2022-12-12 |
| K210124 | 2021-10-19 |
| K191109 | 2020-01-22 |
| K191208 | 2019-10-11 |
| K181784 | 2018-11-30 |
| K162415 | 2017-03-15 |
| K150476 | 2016-04-15 |
| K093145 | 2010-08-13 |
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.