FDA device listing

The AposTherapy System

FDA device listing 1262713442 · APOS MEDICAL ASSETS LTD

Key facts

Proprietary names The AposTherapy System
Owner/operator APOS MEDICAL ASSETS LTD
Owner/operator number 9066682
Premarket submissions K182090
Product codes QDT
Device names QDT - Shoe With Adjustable Sole Units
Device class Class I
Classification regulations (21 CFR) 890.3475
Review panels Physical Medicine
Registered establishments APOS Medical Assets Ltd
Establishment registrations 3004784464
FEI numbers 3004784464
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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