FDA device listing

Vehicle, Motorized 3-Wheeled

FDA device listing 1572085547 · Metro Mobility USA LLC

Key facts

Owner/operator Metro Mobility USA LLC
Owner/operator number 10087406
Premarket submissions K231472
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 METRO MOBILITY USA LLC
Establishment registrations 3026585646
FEI numbers 3026585646
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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

Browse all FDA device listings