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Ranger Ivy FBC01

by Anhui JBH Medical Apparatus Co., Ltd.

Ranger Ivy FBC01 is an assistive scooter (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Anhui JBH Medical Apparatus Co., Ltd., cleared under FDA 510(k) K212090 on 22 Apr 2022 and listed in FDA GUDID since 28 Jun 2025 (UDI-DI 06973175530846), 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) K212090

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 Number06973175530846 UDI-DI Date28 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212090 Date22 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212090 decided 22 Apr 2022 Active
  • FDA GUDID UDI-DI 06973175530846 listed 28 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212090
  2. Listed FDA GUDID 06973175530846

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ranger Ivy
Generic name
Assistive scooter, electric-motor-driven
Model / reference
FBC01
Primary DI / UDI-DI
06973175530846
510(k) Number
FDA product code
INI
GMDN term
Assistive scooter, electric-motor-driven
Device class
Class II
Regulation number
890.3800
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Anhui Jbh Medical Apparatus Co., Ltd

See all devices from Anhui Jbh Medical Apparatus Co., Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)