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Journey Health & Lifestyle N5519

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd

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 Number06978949462538 UDI-DI Date19 Dec 2025ListedStatusListed 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  • Withdrawn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
Journey Health & Lifestyle
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Reference
N5519
Primary DI / UDI-DI
06978949462538
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 Safe

Related devices

Cleared under the same submission (K070501)

Show all (12)

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

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

Properties

  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: 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