Data / Medical devices / South Korea / Inertia Inc.
Inertia Inc.: FDA-registered device maker in Daejeon,, South Korea, 1 510(k) clearance
Inertia Inc. is registered with the FDA (registration 3023278903) in Daejeon,, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023278903
- Address
- 193, Munji-ro, Yuseong-gu, Daejeon,, South Korea, 34051
- Owner or operator
- INERTIA Inc. (10085566)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 3, 2022
- Registered through
- 2026
- Brand names listed
- INERTIA THE COOL ORGANIC COTTON COVER PADS, INERTIA THE COOL ORGANIC COTTON COVER PERIOD UNDERWEAR, INERTIA THE PRISM, Inertia Organic Cotton Cover Period Underwear The Prism (Large), Inertia Organic Cotton Cover Period Underwear The Prism (Regular), Inertia Organic Cotton Cover Period Underwear The Prism (X-Large), Inertia organic cotton cover pads the perfection (large), Inertia organic cotton cover pads the perfection (regular) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 22, 2019 | K182817 | CottonDay Tampon | HEB | Substantially Equivalent | Taebong Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2019. 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.