Home › Device types › LOF
Stimulator, Bone Growth, Non-Invasive
FDA product code LOF · Class 2 · Orthopedic
205
Registered devices
1,433
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
PEMF - PHYSIO-STIM — Orthofix US LLCXstim — Xstim, IncBiomet EBI Bone Healing System — EBI, LLCBiomet OrthoPak Non-invasive Stimulator — EBI, LLCBiomet SpinalPak Non-invasive Spine Fusion Stimulator System — EBI, LLCPEMF - SPINAL-STIM — Orthofix US LLCPEMF - PHYSIO-STIM — Orthofix US LLCBiomet EBI Bone Healing System — EBI, LLCPEMF - PHYSIO-STIM — Orthofix US LLCPhysio-Stim — Orthofix US LLCXstim — Xstim, IncBiomet SpinalPak Non-invasive Spine Fusion Stimulator System — EBI, LLCBiomet EBI Bone Healing System — EBI, LLCOrthofix Osteogenesis Stimulator — Orthofix US LLCPhysio-Stim — Orthofix US LLCBiomet SpinalPak / OrthoPak — EBI, LLCBiomet EBI Bone Healing System — EBI, LLCOrthofix Osteogenesis Stimulator — Orthofix US LLCOrthofix Osteogenesis Stimulator — Orthofix US LLCPhysio-Stim — Orthofix US LLCBiomet OrthoPak Non-invasive Bone Growth Stimulator System — EBI, LLCActaStim-S — THERAGEN, LLCPhysio-Stim — Orthofix US LLCPEMF - PHYSIO-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. |
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