Data / Medical devices / China / Shenzhen Changkun Technology Co., Ltd.
Shenzhen Changkun Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Shenzhen Changkun Technology Co., Ltd. is registered with the FDA (registration 3009617411) in Shenzhen Guangdong, China. It lists 11 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009617411
- Address
- 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community Kengzi Street, Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen Changkun Technology Co., Ltd. (10071297)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 21, 2020
- Registered through
- 2026
- Brand names listed
- Arm Electronic Sphygmomanometer /Arm Blood Pressure Monitor, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A156, Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models: CK-A159, CK-A1912, CK-A1915, CK-A1915P, CK-A1916, Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models:CK-A1916P, CK-A2006, CK-A2008, X180, CK-A158, CK-A168, Electric Breast Pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3), Electric breast pump with models MY-371,MY-372,MY-373,MY-374,MY-375,MY-376,MY-378,MY-379,MY-380, V3, Electric breast pump with models MY-381,MY-382,MY-383,MY-384,MY-385,MY-386,MY-387,MY-388,MY-389,MY-390, Finger Pulse Oximeter Model: X1906P,X1805,X1805P,X1906,X1907,X1907P,X1908,X1908P,X1909,X1909P, Hearing Aid, Air-Conduction, Prescription D8, D9 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Thermometer Kit | PXH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | HGX | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| May 6, 2026 | K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | KPI | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K231595 | Electric Breast Pump | HGX | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K221798 | Finger Pulse Oximeter, Model: X1906P | DQA | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| January 27, 2021 | K193387 | Arm Electronic Sphygmomanometer | DXN | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| January 27, 2021 | K193386 | Wrist Electronic Sphygmomanometer | DXN | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| June 17, 2020 | K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | FLL | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Continuous Measurement Thermometer
- All makers of Pump, Breast, Powered
Updated June 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.