Data / Medical devices / China / Shenzhen Carewell Electronics Co., Ltd.
Shenzhen Carewell Electronics Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Carewell Electronics Co., Ltd. is registered with the FDA (registration 3010089768) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010089768
- Address
- Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street Nanshan District, Shenzhen Guangdong, China, 518108
- Owner or operator
- Shenzhen Carewell Electronics Co., Ltd. (10047185)
- Roles
- Manufacturer
- First device listed
- July 15, 2014
- Registered through
- 2026
- Brand names listed
- Carewell, Model AI-ECG Platform, Programmable Diagnostic Computer, electrocardiogram ECG-1112M
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 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 |
|---|---|---|---|---|---|---|
| November 19, 2018 | K180432 | AI-ECG Platform | DQK | Substantially Equivalent | Shenzhen Carewell Electronics., Ltd. | accessdata.fda.gov |
| April 25, 2012 | K113485 | ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Shenzhen Carewell Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2018. 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.