gudid Primary ID: M4

XSTO (UDI M4)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The XSTO (Model/Catalog Number: M4) is a medical device manufactured by XSTO CO., LTD.. This product is indexed under FDA Product Code / Category Classification ITI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: M4
Product Code / EMDN: ITI
Device Name: Powered wheelchair (mobility robot), Model: M4; OTC
Database Sync Date: 2026-08-09 09:06:36

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of XSTO?

The registered manufacturer of record for XSTO is XSTO CO., LTD..

What is the Primary UDI-DI identifier for XSTO?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M4.

What classification code is assigned to this device?

This device is registered under product classification code ITI.

Similar Classification Devices (ITI)

Other Devices by XSTO CO., LTD.

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