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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, ultrasound and muscle, for use other than applying therapeutic deep
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.
Product CodeLPQ
Regulation Number 890.5870
Device Class 2

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