FDA device listing

Edge 2 (KITASMB1940)

FDA device listing 1049108024 · FEISHEN VIETNAM COMPANY LIMITED

Key facts

Proprietary names Edge 2 (KITASMB1940)
Owner/operator FEISHEN VIETNAM COMPANY LIMITED
Owner/operator number 10092385
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 FEISHEN VIETNAM COMPANY LIMITED
Establishment registrations 3035382637
FEI numbers 3035382637
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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