Data / Medical devices / South Korea / REMED Co., Ltd.
REMED Co., Ltd.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 3 510(k) clearances
REMED Co., Ltd. is registered with the FDA (registration 3019055598) in Cheongju-si Chungbuk, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019055598
- Address
- 84, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28161
- Owner or operator
- REMED Co.,Ltd. (10084081)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 16, 2022
- Registered through
- 2026
- Brand names listed
- ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System, Compact II, SPRY TMS, Talent-Pro Electromagnetic Stimulator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 2 | Contract manufacturer, 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 6, 2022 | K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System | OBP | Substantially Equivalent | Remed Co., Ltd. | accessdata.fda.gov |
| November 26, 2021 | K202537 | ALTMS Magnetic Stimulation Therapy System | OBP | Substantially Equivalent | Remed Co., Ltd. | accessdata.fda.gov |
| May 6, 2021 | K202031 | Talent-Pro Electromagnetic Stimulator | IPF | Substantially Equivalent | Remed Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 6, 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.