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Mobility Scooter, Model W3468

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

510(k) K220207

Mobility Scooter, Model W3468 is a medical device (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Zhejiang Innuovo Rehabilitation Devices Co., Ltd., cleared under FDA 510(k) K220207 on 24 Mar 2022, active as of 8 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220207 Date24 Mar 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
INI
FDA applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Device class
Class II
Regulation
21 CFR Part 890.3800
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).

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