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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 the device name listed in this FDA 510(k) record. The listed applicant is Xbody Hungary Kft.. It received FDA 510(k) clearance on 2019-04-05 under 510(k) 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. The listed applicant is Xbody Hungary Kft.. The 510(k) number is K190038.

When did Xbody Newave USA receive FDA 510(k) clearance?

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

Who is the listed applicant for Xbody Newave 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 Newave USA?

The FDA product code for Xbody Newave 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.

K242926XBody Go USA, XBody Pro USAK221200XBody Go USA, XBody Pro USA

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.

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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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