FDA product code LOF: Stimulator, Bone Growth, Non-Invasive

LOF is the FDA product code for stimulator, bone growth, non-invasive. It is a Class II device, regulated under 21 CFR 890.5870 and reviewed by the Orthopedic panel. Devices under LOF reach the market by 510(k); FDA lists no cleared 510(k)s for it. 10 PMA applications cite this product code. FDA has posted 5 recalls for LOF devices, 4 initiated in the last five years.

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.

Classification

Recalls for LOF devices

5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-03-22.

Frequently asked questions

What is FDA product code LOF?

LOF is the FDA product code for stimulator, bone growth, non-invasive. It is a Class II device, regulated under 21 CFR 890.5870 and reviewed by the Orthopedic panel.

What device class is LOF?

Class II, regulation 21 CFR 890.5870. Typical premarket route: 510(k).

Have LOF devices been recalled?

Yes: 5 product recalls across 2 recall events; the most recent began 2024-03-22.

Next steps

• Run an FDA pathway report with predicate devices for product code LOF
• Run a recall and safety report across every LOF manufacturer
• Watch product code LOF for new clearances and recalls

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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