Stimulator, Bone Growth, Non-Invasive

What Is This Device?

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.

What Is FDA Product Code LOF?

Stimulator, Bone Growth, Non-Invasive is FDA product code LOF, Class 2, 21 CFR 890.5870.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Device Design (4) and Nonconforming Material/Component (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.