Data / Medical devices / China / Isen Tech.&trading Co., Ltd.
Isen Tech.&trading Co., Ltd.: FDA-registered device maker in Beijing, China, 1 510(k) clearance
Isen Tech.&trading Co., Ltd. is registered with the FDA (registration 3011522961) in Beijing, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 26, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011522961
- Address
- 3 Gaoli Zhang Road Room 302A, Floor 3, Building 11, Beijing, China, 100095
- Owner or operator
- ISEN Tech.&Trading Co., Ltd. (10054871)
- Roles
- Manufacturer
- First device listed
- May 7, 2017
- Registered through
- 2026
- Brand names listed
- AirC, IG, IG Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nystagmograph | GWN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Caloric-Air | KHH | 1 | 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 |
|---|---|---|---|---|---|---|
| April 26, 2016 | K152727 | ISEN-Goggles | GWN | Substantially Equivalent | Isen Tech & Trading Company, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 26, 2016. 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.