Xbody Hungary Kft.
HungaryFDA applicant, unverified
- Devices
- 6
What Xbody Hungary Kft. makes
Xbody Hungary Kft. manufactures transcutaneous neuromuscular electrical stimulation (TENS/NMES) devices designed for physical therapy applications, including portable and professional-grade systems for muscle stimulation and pain management.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Xbody Newave USA Ref K190038
Regimes: 510(k) Registry: 510(k)XBody Go USA, XBody Pro USA Ref K242926
Regimes: 510(k) Registry: 510(k)XBody Go USA, XBody Pro USA Ref K221200
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 366728377
Frequently asked questions
How many devices does Xbody Hungary Kft. have in the registry?
The registry currently lists 6 devices for Xbody Hungary Kft.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xbody Hungary Kft.'s devices?
Among its 6 most recently registered devices, Xbody Hungary Kft. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Xbody Hungary Kft.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Xbody Hungary Kft.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xbody Hungary Kft. in the registry?
The most recently registered devices listed for Xbody Hungary Kft. include XBody Go USA, XBody Newave USA, XBody Pro USA and XBody Go USA, XBody Pro USA.