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FDA 510(k)

XBody Go USA, XBody Pro USA

K-Number: K242926 · 2025-05-30

Decision Date2025-05-30
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

XBody Go USA, XBody Pro USA is the device name listed in this FDA 510(k) record. The listed applicant is Xbody Hungary Kft.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242926. 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 Go USA, XBody Pro USA?

XBody Go USA, XBody Pro USA is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Xbody Hungary Kft.. The 510(k) number is K242926.

When did XBody Go USA, XBody Pro USA receive FDA 510(k) clearance?

XBody Go USA, XBody Pro USA received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242926.

Who is the listed applicant for XBody Go USA, XBody Pro USA?

The FDA 510(k) record lists Xbody Hungary Kft. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XBody Go USA, XBody Pro USA?

The FDA product code for XBody Go USA, XBody Pro USA is NGX.

Other records listing Xbody Hungary Kft. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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