FDA product code LWB: Stimulator, Functional Neuromuscular, Scoliosis

LWB is the FDA product code for stimulator, functional neuromuscular, scoliosis. It is a Class III device, reviewed by the Physical Medicine panel. Devices under LWB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.

Classification

FieldValue
Device nameStimulator, Functional Neuromuscular, Scoliosis
Device classClass III
Review panelPM — Physical Medicine
Medical specialtyUnknown
Premarket routePMA

Recalls for LWB devices

openFDA lists no recalls for product code LWB.

Frequently asked questions

What is FDA product code LWB?

LWB is the FDA product code for stimulator, functional neuromuscular, scoliosis. It is a Class III device, reviewed by the Physical Medicine panel.

What device class is LWB?

Class III. Typical premarket route: PMA.

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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