FDA device listing

iBOT PMD

FDA device listing 1211038140 · Mobius Mobility LLC

Key facts

Proprietary names iBOT PMD
Owner/operator Mobius Mobility LLC
Owner/operator number 10057767
Premarket submissions K172601
Product codes IMK
Device names IMK - Wheelchair, Stair Climbing
Device class Class II
Classification regulations (21 CFR) 890.3890
Review panels Physical Medicine
Registered establishments MOBIUS MOBILITY LLC
Establishment registrations 3014522447
FEI numbers 3014522447
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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

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