Skip to content

Xsto M4

by Xsto Co., Ltd. 2 variants

Xsto M4 is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Xsto Co., Ltd., cleared under FDA 510(k) K242358 on 3 Apr 2025, registered in EUDAMED and listed in FDA GUDID since 16 Jun 2025 (UDI-DI 06975052650104), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242358

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975052650104 UDI-DI Date16 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK242358 Date3 Apr 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K242358 decided 3 Apr 2025 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 06975052650104 listed 16 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242358
  2. Listed FDA GUDID 06975052650104

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xsto
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Model / reference
M4
Primary DI / UDI-DI
06975052650104
510(k) Number
FDA product code
ITI
GMDN term
Electric-motor-driven wheelchair, occupant-controlled
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electric-motor-driven wheelchair, occupant-controlled

Cleared under the same submission (K242358)

Similar devices in this category

Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.

Other devices from Xsto Co., Ltd.

See all devices from Xsto Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)