FDA device listing

e-Throne Folding Wheelchairs

FDA device listing 1526983937 · Golden Motor Technology Co., Ltd

Key facts

Proprietary names e-Throne Folding Wheelchairs
Owner/operator Golden Motor Technology Co., Ltd
Owner/operator number 10084306
Premarket submissions K191105
Product codes ITI
Device names ITI - Wheelchair, Powered
Device class Class II
Classification regulations (21 CFR) 890.3860
Review panels Physical Medicine
Registered establishments GOLDEN MOTOR TECHNOLOGY CO., LTD
Establishment registrations 3021959198
FEI numbers 3021959198
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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