Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011792111

FEI Number

3011792111

Entity Name

XBody Hungary Zrt.

City/State/Country

Gyor, HU

Establishment Address

Torok Ignac u. 66, Gyor 9028, HU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

XBody Hungary Zrt. (Owner Number: 10060736)

Owner / Operator Contact Address

Gyorgy Aladar u. 35-39., Budapest, HU-BU 1125, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190038

PMA Number

N/A

All Registered Proprietary Names

XBody Go USA, XBody Pro USA, XBody DrySuit, XBody DryWear XBody Newave USA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-06-16
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-06-18

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

XBody Hungary Zrt.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011792111. Last updated year: 2026. Please use registration number 3011792111 when referencing this establishment in official correspondence.