Home › Device types › LOF
Stimulator, Bone Growth, Non-Invasive
FDA product code LOF · Class 2 · Orthopedic
207
Registered devices
1,444
Adverse events
5
Recalls
1
510(k) clearances
Devices with this code
Biomet OrthoPak Non-invasive Stimulator — EBI, LLCBiomet EBI Bone Healing System — EBI, LLCPEMF - PHYSIO-STIM — Orthofix US LLCXstim — Xstim, IncActaStim-S — THERAGEN, LLCPhysio-Stim — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCEXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLCPhysio-Stim — Orthofix US LLCBiomet EBI Bone Healing System — EBI, LLCPEMF - CERVICAL-STIM — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCBiomet SpinalPak / OrthoPak — EBI, LLCPEMF - SPINAL-STIM — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCBiomet SpinalPak / OrthoPak — EBI, LLCPEMF - SPINAL-STIM — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCActaStim-S — THERAGEN, LLCPhysio-Stim — Orthofix US LLCXstim — Xstim, IncActaStim-S — THERAGEN, LLCPEMF - CERVICAL-STIM — Orthofix US LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to |
| 2024-03-22 | EBI, LLC | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to |
| 2020-12-17 | Bioventus, LLC | Product may contain white particulates that are microbial in nature. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.