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Navione X0EJ

by Yamaha Motor Co., Ltd. 15 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580027190350 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Navione
Generic Name
Wheelchair electric-motor-driven propulsion system
Model / Reference
X0EJ
Primary DI / UDI-DI
04580027190350
510(k) Number
FDA Product Code
ITI
GMDN Term
Wheelchair electric-motor-driven propulsion system
Device Class
Class II
Regulation Number
890.3860
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K140204)

Show all (12)

Other devices from Yamaha Motor Co., Ltd.

See all devices from Yamaha Motor Co., Ltd. →

Properties

  • Lot / Batch Number
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No