FDA device listing

Shoulder Abduction Sling

FDA device listing 1186439973 · ELITE ORTHOPAEDICS, INC.

Key facts

Proprietary names Shoulder Abduction Sling
Owner/operator ELITE ORTHOPAEDICS, INC.
Owner/operator number 9006401
Product codes IQQ
Device names IQQ - Joint, Shoulder, External Limb Component
Device class Class I
Classification regulations (21 CFR) 890.3420
Review panels Physical Medicine
Registered establishments ELITE ORTHOPAEDICS, INC.
Establishment registrations 2028810
FEI numbers 1000135616
Establishment operations Manufacturer, Specification Developer
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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