LOF · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 890.5870
Classification
FDA Product Code
LOF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5870
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.