Data / Medical devices / South Korea / Rev-Med Inc.
Rev-Med Inc.: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 1 510(k) clearance
Rev-Med Inc. is registered with the FDA (registration 3015466811) in Yongin-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015466811
- Address
- 437, Gogi-ro, Suji-gu, Yongin-si Gyeonggi, South Korea, 16801
- Owner or operator
- REV-MED Inc. (10093031)
- Roles
- Manufacturer
- First device listed
- March 20, 2025
- Registered through
- 2026
- Brand names listed
- Hilthera 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 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 |
|---|---|---|---|---|---|---|
| January 7, 2015 | K141861 | HILTHERA 4.0 | ILY | Substantially Equivalent | Jeisys Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2015. 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.