FDA device listing

Orthosis, Truncal/Orthosis, Limb

FDA device listing 1092279440 · Azad International (H.K.) Ltd.

Key facts

Owner/operator Azad International (H.K.) Ltd.
Owner/operator number 10052664
Product codes MRI
Device names MRI - Orthosis, Truncal/Orthosis, Limb
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments AZAD INTERNATIONAL (H.K.) LTD.
Establishment registrations 1000282694
FEI numbers 1000282694
Establishment operations Foreign Exporter
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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