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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, bone growth, non-invasive
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.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeLOF
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 890.5870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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