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Power Wheelchair

by Beijing OrionStar Technology Co., Ltd

Ref OS-R-M01SModel OS-R-M01S OS-R-M02S OS-R-M03S OS-R-M04S OS-R-M05S OS-R-M01I OS-R-M02I OS-R-M03I OS-R-M04I OS-R-M05I OS-R-M01M OS-R-M02M OS-R-M03M OS-R-M04M OS-R-M05M OS-R-M01A OS-R-M02A OS-R-M03A OS-R-M04A OS-R-M05A

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253952↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06978951240001 UDI-DI Date12 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK253952 Date7 Apr 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number697895124PWOSRMAQ Basic UDI-DI 06978951240001UDI-DIDate11 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
OrionStar
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Device Name
Power Wheelchair
Model / Reference
OS-R-M01S OS-R-M02S OS-R-M03S OS-R-M04S OS-R-M05S OS-R-M01I OS-R-M02I OS-R-M03I OS-R-M04I OS-R-M05I OS-R-M01M OS-R-M02M OS-R-M03M OS-R-M04M OS-R-M05M OS-R-M01A OS-R-M02A OS-R-M03A OS-R-M04A OS-R-M05A, OS-R-M01S
Primary DI / UDI-DI
06978951240001
Basic UDI-DI
697895124PWOSRMAQ
510(k) Number
FDA Product Code
ITI
EMDN Code
Y122127 Electric wheelchairs
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.3860
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000048929
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing OrionStar Technology Co., Ltd.

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No