LOF

Stimulator, Bone Growth, Non-Invasive

Product code

LOF

Device name

Stimulator, Bone Growth, Non-Invasive

Device class

Class 2

21 CFR

21 CFR 890.5870

Medical specialty

Orthopedic

Marketing pathway

510(K)

FDA classification definition

A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.

Definition text from the FDA device classification database (U.S. federal government work, public domain).