Data / Medical devices / South Korea / Cosmo Robotics Co., Ltd
Cosmo Robotics Co., Ltd: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Cosmo Robotics Co., Ltd is registered with the FDA (registration 3018091330) in Seoul, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018091330
- Address
- 20 Ace Techno Tower 5th, 801, 20 Digital-ro 31-gil Guro-gu, Seoul, South Korea, 08380
- Owner or operator
- Cosmo Robotics Co., Ltd (10080183)
- Roles
- Manufacturer
- First device listed
- January 18, 2021
- Registered through
- 2026
- Brand names listed
- Cosaver, Cosuit, EA Bambini, EA Bambini Kids, EA Personal, ExoAtlet 2H, ExoAtlet II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Exoskeleton | PHL | 2 | Manufacturer | accessdata.fda.gov |
| System, Isokinetic Testing And Evaluation | IKK | 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 |
|---|---|---|---|---|---|---|
| July 16, 2021 | K201473 | ExoAtlet-II | PHL | Substantially Equivalent | Exoatlet Asia Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 16, 2021. 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.