XBody Go USA, XBody Pro USA— 510(k) K242926

Substantially Equivalent

Xbody Hungary Kft.

FDA 510(k) clearance K242926 for XBody Go USA, XBody Pro USA, Substantially Equivalent on 2025-05-30. Applicant: Xbody Hungary Kft.. Device class: 2.

Clearance details

Applicant: Xbody Hungary Kft.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-09-24
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budapest, HU

Download summary PDF View on FDA.gov ↗

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More clearances from Xbody Hungary Kft.

K221200 — XBody Go USA, XBody Pro USA2023-01-31
K190038 — Xbody Newave USA2019-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.