← Back to catalogue

Powered wheelchair (mobility robot)

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref XSTO M4 Pro510(k) K242358

by Xsto Co., Ltd.

Identity

Trade Name
Powered wheelchair (mobility robot) EUDAMED
Device Name
Powered wheelchair (mobility robot) EUDAMED
Model / Reference
XSTO M4 Pro EUDAMED

Identifiers

Primary DI / UDI-DI
06975052650180 EUDAMED
Basic UDI-DI
697505265XSTOM4ProQ6 EUDAMED
510(k) Number
K242358 FDA 510(k)
FDA Product Code
ITI FDA 510(k)
EMDN Code
Y122127 ELECTRIC WHEELCHAIRS EUDAMED

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Powered wheelchair (mobility robot) by Xsto Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Xsto Co., Ltd.
EUDAMED SRN
CN-MF-000018902
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (2)

  • EUDAMED b1d8037c-03f2-4498-9460-07940882cb9a 61 fields · synced Jul 11, 2026
  • FDA 510(k) K242358 24 fields · synced May 18, 2026