Data / Medical devices / Hungary / XBody Hungary Zrt.
XBody Hungary Zrt.: FDA-registered device maker in Gyor, Hungary, 3 510(k) clearances
XBody Hungary Zrt. is registered with the FDA (registration 3011792111) in Gyor, Hungary. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011792111
- Address
- Torok Ignac u. 66, Gyor, Hungary, 9028
- Owner or operator
- XBody Hungary Zrt. (10060736)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 18, 2019
- Registered through
- 2026
- Brand names listed
- XBody Go USA, XBody Pro USA, XBody Go USA, XBody Pro USA, XBody DrySuit, XBody DryWear, XBody Newave USA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 30, 2025 | K242926 | XBody Go USA, XBody Pro USA | NGX | Substantially Equivalent | Xbody Hungary Kft. | accessdata.fda.gov |
| January 31, 2023 | K221200 | XBody Go USA, XBody Pro USA | NGX | Substantially Equivalent | Xbody Hungary Kft. | accessdata.fda.gov |
| April 5, 2019 | K190038 | Xbody Newave USA | NGX | Substantially Equivalent | Xbody Hungary Kft. | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2025. 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.