Product code LOF— Unknown
ETHICON TEMPORARY CARDIAC PACING WIRE
- Classification name
- Stimulator, Bone Growth, Non-Invasive
- Device class
- Class 2
- Regulation
- 21 CFR 890.5870
- Advisory panel
- Unknown
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code LOF
FDA has cleared device under product code LOF, all in 1982, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code LOF
Adverse events under product code LOF
product code LOF- Death
- 3
- Injury
- 1,058
- Total
- 1,061
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LOF
Data sourced from openFDA. This site is unofficial and independent of the FDA.