LOF — Stimulator, Bone Growth, Non-Invasive Class II
FDA product code LOF covers "Stimulator, Bone Growth, Non-Invasive", a Class II medical device regulated under 21 CFR 890.5870. Submissions are reviewed by the Orthopedic panel.
Classification Details
- Product Code
- LOF
- Device Class
- Class II
- Regulation Number
- 890.5870
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.