Data / Medical devices / China / Hangzhou VivaLNK Medical Technology Co.,LTD.
Hangzhou VivaLNK Medical Technology Co.,LTD.: FDA-registered device maker in Hangzhou Zhejiang, China, 5 510(k) clearances
Hangzhou VivaLNK Medical Technology Co.,LTD. is registered with the FDA (registration 3019737388) in Hangzhou Zhejiang, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 3, 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
- 3019737388
- Address
- Room 502, Floor 5, Building 2, No.2, 8th Avenue, Baiyang Sub-district, Qiantang District, Hangzhou Zhejiang, China, 310000
- Owner or operator
- VivaLnk Inc (10049171)
- Roles
- Exporter to the US
- First device listed
- February 2, 2017
- Registered through
- 2026
- Brand names listed
- Checkme O2/SpO2oxiband sleepmonitor, Continuos monitoring thermometer, Continuos monitoring thermometer - VV200, Disposable Hydrogel Adhesive, Fever Scout Adhesive, Fever Scout Continuos monitoring thermometer, Hydrogel Adhesive, Infrared Thermometer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| December 20, 2022 | K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 8, 2022 | K203812 | Oxyfit Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| January 7, 2020 | K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | DRG | Substantially Equivalent | VivaLNK, Inc. | accessdata.fda.gov |
| December 2, 2019 | K191088 | Checkme O2 Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| January 19, 2017 | K162137 | Fever Scout Continuous Monitoring thermometer | FLL | Substantially Equivalent | VivaLNK, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Continuous Measurement Thermometer
- All makers of Tape And Bandage, Adhesive
- All makers of Oximeter
Updated December 20, 2022. 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.