Data / Medical devices / South Korea / WINBACK GO EAST Co Ltd
WINBACK GO EAST Co Ltd: FDA-registered device maker in Wonju-si Gangwon, South Korea, 5 510(k) clearances
WINBACK GO EAST Co Ltd is registered with the FDA (registration 3016512343) in Wonju-si Gangwon, South Korea. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016512343
- Address
- 161, Usangongdan-Gil, Wonju-si Gangwon, South Korea, 26335
- Owner or operator
- WINBACK GO EAST Co Ltd (10062809)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 9, 2020
- Registered through
- 2026
- Brand names listed
- BACK 3, BACK 3TX, BACK 4, Back 3 Color, Hi-TENS, Massager, Radiofrequency Induced Heat Winback Back 3SE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 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 |
|---|---|---|---|---|---|---|
| September 14, 2023 | K230167 | BACK 4 | IPF | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| July 19, 2023 | K230037 | BACK 3 | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| March 1, 2023 | K220014 | RSHOCK | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| November 1, 2022 | K214090 | Back 3 COLOR | PBX | Substantially Equivalent | Swims America Corp | accessdata.fda.gov |
| September 18, 2017 | K162828 | Winback Back 3SE | PBX | Substantially Equivalent | Winback USA Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Muscle, Powered
Updated September 14, 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.