Data / Medical devices / South Korea / Imani
Imani: FDA-registered device maker in Yongin Gyeonggi, South Korea, 3 510(k) clearances
Imani is registered with the FDA (registration 3018159965) in Yongin Gyeonggi, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018159965
- Address
- 147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea., Yongin Gyeonggi, South Korea, 17135
- Owner or operator
- imani (10080975)
- Roles
- Manufacturer
- First device listed
- March 9, 2021
- Registered through
- 2026
- Brand names listed
- imani i1, imani i1Plus, imani i2, imani i2Plus, imani i2Plus Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 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 |
|---|---|---|---|---|---|---|
| March 3, 2023 | K222573 | imani i2Plus Breast Pump | HGX | Substantially Equivalent | Imani Co. | accessdata.fda.gov |
| March 1, 2021 | K202037 | imani i2 | HGX | Substantially Equivalent | Imani Co. | accessdata.fda.gov |
| February 26, 2021 | K202045 | imani i1 | HGX | Substantially Equivalent | Imani Co. | accessdata.fda.gov |
Compare with other makers
Updated March 3, 2023. 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.