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Wheelchair Powered GP164

by Golden Brothers, Inc

Wheelchair Powered GP164 is a wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Golden Brothers, Inc, cleared under FDA 510(k) K011153 on 29 May 2001 and listed in FDA GUDID since 23 Apr 2020 (UDI-DI B247GP164), active as of 23 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 23 Oct 2026

Documents

510(k) K011153

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB247GP164 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011153 Date29 May 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011153 decided 29 May 2001 Active
  • FDA GUDID UDI-DI B247GP164 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011153
  2. Listed FDA GUDID B247GP164

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wheelchair Powered
Generic name
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Model / Ref / Catalog
GP164
Primary DI / UDI-DI
B247GP164
510(k) Number
FDA product code
ITI
GMDN term
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITI (Wheelchair, Powered).

Other devices from Golden Brothers, Inc

See all devices from Golden Brothers, Inc →

Properties

  • Prescription use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)