Data / Medical devices / South Korea / Vsi Co., Ltd.
Vsi Co., Ltd.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 2 510(k) clearances
Vsi Co., Ltd. is registered with the FDA (registration 3015502499) in Cheongju-si Chungbuk, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015502499
- Address
- 151-33, Namseok-ro, Nami-myeon, Seowon-gu, Cheongju-si Chungbuk, South Korea, 28182
- Owner or operator
- VSI Co., Ltd. (10085570)
- Roles
- Manufacturer
- First device listed
- July 4, 2022
- Registered through
- 2026
- Brand names listed
- CLAROX, CLAROX X4, CLAROX plus, X4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 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 |
|---|---|---|---|---|---|---|
| September 13, 2022 | K221417 | CLAROX plus (Model: VX-100) | IZL | Substantially Equivalent | Vsi Co., Ltd. | accessdata.fda.gov |
| June 29, 2022 | K221286 | CLAROX | EHD | Substantially Equivalent | Vsi Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 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.