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XBody Go USA, XBody Pro USA

by Xbody Hungary Kft. 2 variants

510(k) K242926

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242926 Date30 May 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NGX
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The XBody Go USA and XBody Pro USA are machines with electronic muscle stimulation based on EMS technology. They are specifically designed as an addition to other sports and for training muscles, and must be used only for healthy muscles.

These devices are classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls. They were cleared by the FDA under 510(k) submission K242926 on May 30, 2025, following a traditional review process. The manufacturer is Xbody Hungary Kft., located in Budapest, Hungary.

Other devices from Xbody Hungary Kft.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the XBody Go USA and XBody Pro USA used for?

    These devices are powered muscle stimulators designed as an addition to sports training for conditioning healthy muscles, using EMS technology to stimulate muscle activity.

  • How are the XBody Go USA and XBody Pro USA supplied and what is their intended use?

    They are supplied as standalone machines for muscle conditioning and must be used only on healthy muscles as an adjunct to sports and training activities, not for medical treatment or rehabilitation.

  • What regulatory pathway was used for the XBody Go USA and XBody Pro USA?

    The devices were cleared by the FDA through a traditional 510(k) submission (K242926) on May 30, 2025, based on substantial equivalence to a predicate device under product code NGX for powered muscle stimulators.