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Youhuan Yh-E7007

by Ningbo Youhuan Automation Technology Co., Ltd

Youhuan Yh-E7007 is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Ningbo Youhuan Automation Technology Co., Ltd, cleared under FDA 510(k) K240638 on 16 Sep 2024 and listed in FDA GUDID since 30 Jan 2025 (UDI-DI 06975028630215), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K240638

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975028630215 UDI-DI Date30 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240638 Date16 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240638 decided 16 Sep 2024 Active
  • FDA GUDID UDI-DI 06975028630215 listed 30 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240638
  2. Listed FDA GUDID 06975028630215

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Youhuan
Generic name
Electric-motor-driven wheelchair, occupant-controlled
Model / reference
YH-E7007
Primary DI / UDI-DI
06975028630215
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

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Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)