FDA device listing

Back support with suspenders max soos 3

FDA device listing 1964859725 · HAMECO., JSC

Key facts

Proprietary names Back support with suspenders max soos 3
Owner/operator HAMECO., JSC
Owner/operator number 9096901
Product codes IQE
Device names IQE - Orthosis, Lumbar
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments HAMECO HY CO., LTD
Establishment registrations 3006400320
FEI numbers 3006400320
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

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