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Power Wheelchair

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. 4 variants

Ref W5538Model N5513A,N5515,N5515A,N5516,N5516A,N5516C,W5517,N5517A,N5519,W5521,W5521B,N5525,W5526,W5536,W5536A,W5536B,W5538,N5901,W5905,W5905A,W5907,Q50R Carbon,N5909,N5909A,W5211,W5211B,W5213,W5213C,W5216,N5909D,W5915B,W5915C,W5915D,N5919,N5516D,N5516E,N5516F

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06978949462835 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697894946PW001Y3 Basic UDI-DI 06978949462835UDI-DIDate8 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 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Reference
N5513A, N5515, N5515A, N5516, N5516A, N5516C, W5517, N5517A, N5519, W5521, W5521B, N5525, W5526, W5536, W5536A, W5536B, W5538, N5901, W5905, W5905A, W5907, Q50R Carbon, N5909, N5909A, W5211, W5211B, W5213, W5213C, W5216, N5909D, W5915B, W5915C, W5915D, N5919, N5516D, N5516E, N5516F
Primary DI / UDI-DI
06978949462835
Basic UDI-DI
697894946PW001Y3
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
Poland
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-000008727
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

See all devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd. →

Properties

  • Administering Medicine
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No