Data / Medical devices / China / Huizhou Maxway Technology Co., Ltd.
Huizhou Maxway Technology Co., Ltd.: FDA-registered device maker in Huizhou Guangdong, China, 1 510(k) clearance
Huizhou Maxway Technology Co., Ltd. is registered with the FDA (registration 3011119387) in Huizhou Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 12, 2020. 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
- 3011119387
- Address
- No.9, Dongsheng South Road, Chenjiang, Zhongkai Hi-Tech District, Huizhou Guangdong, China, 516080
- Owner or operator
- Maxway Technology Co., Ltd. (10080027)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 13, 2021
- Registered through
- 2026
- Brand names listed
- BACtrack Skyn, BACtrack T15, BT-T15, Insight Infrared Video Goggles, SK-15, SK-15-AL, SK-15-AS, SK-15-ML and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Nystagmograph | GWN | 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 12, 2020 | K203082 | Insight Infrared Video Goggles | GWN | Substantially Equivalent | Vestibular First | accessdata.fda.gov |
Compare with other makers
Updated November 12, 2020. 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.