FDA product code IMW: Brake, Extension, Wheelchair

IMW is the FDA product code for brake, extension, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. Devices under IMW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameBrake, Extension, Wheelchair
Device classClass I
Regulation21 CFR 890.3920
Review panelPM — Physical Medicine
Medical specialtyPhysical Medicine
Premarket route510(k) exempt

Recalls for IMW devices

openFDA lists no recalls for product code IMW.

Frequently asked questions

What is FDA product code IMW?

IMW is the FDA product code for brake, extension, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.

What device class is IMW?

Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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