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FDA 510(k)

Xbody Newave USA

K-Number: K190038 · 2019-04-05

ApplicantXbody Hungary Kft.
Decision Date2019-04-05
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Xbody Newave USA is a medical device manufactured by Xbody Hungary Kft.. It received FDA 510(k) clearance on 2019-04-05 under approval number K190038. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xbody Newave USA?

Xbody Newave USA is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Xbody Hungary Kft.. The 510(k) number is K190038.

When was Xbody Newave USA approved by the FDA?

Xbody Newave USA received FDA 510(k) clearance on 2019-04-05, under approval number K190038.

What company makes Xbody Newave USA?

Xbody Newave USA is manufactured by Xbody Hungary Kft..

What is the FDA product code for Xbody Newave USA?

The FDA product code for Xbody Newave USA is NGX.

Other Devices by Xbody Hungary Kft.

K221200XBody Go USA, XBody Pro USA K242926XBody Go USA, XBody Pro USA

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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