FDA device listing

Summit

FDA device listing 1893458522 · RIVAL VIETNAM CO.,LTD

Key facts

Proprietary names Summit
Owner/operator RIVAL VIETNAM CO.,LTD
Owner/operator number 10043376
Product codes IQE
Device names IQE - Orthosis, Lumbar
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments RIVAL VIETNAM CO.,LTD
Establishment registrations 3010220099
FEI numbers 3010220099
Establishment operations Contract Manufacturer, 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

Browse all FDA device listings