Stimulator, Bone Growth, Non-Invasive
Stimulator, Bone Growth, Non-Invasive is an external device that delivers pulsed electromagnetic fields (PEMF) or ultrasound energy transcutaneously to promote healing of bone fractures or fusions without surgical implantation, used in the management of delayed unions, non-unions, or as an adjunct to spinal fusion. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LOF; no regulation number has been assigned, and the review panel is Orthopedic. No special flags apply to this device.
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Basic Information
- Product Code
- LOF
- Device Class
- FDA class 2
- Regulation Number
- 890.5870
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.