LPQ · Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Orthopedic · 21 CFR 890.5870 · Class 2
Overview
| Product Code | LPQ |
|---|---|
| Device Name | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep |
| Regulation | 21 CFR 890.5870 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P900009S006 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000 | Bioventus, LLC | Feb 22, 2000 | APPR |
Top Applicants
- Bioventus, LLC — 1 clearance
