FDA device listing

Electrical Scooter - EURO-TAIWAN; WU'S

FDA device listing 1159142737 · WU'S TECH CO., LTD.

Key facts

Proprietary names Electrical Scooter - EURO-TAIWAN; WU'S
Owner/operator WU'S TECH CO., LTD.
Owner/operator number 9041713
Premarket submissions K023168
Product codes INI
Device names INI - Vehicle, Motorized 3-Wheeled
Device class Class II
Classification regulations (21 CFR) 890.3800
Review panels Physical Medicine
Registered establishments WU'S TECH (VIETNAM) Co., Ltd.
Establishment registrations 3007963811
FEI numbers 3007963811
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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