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FDA PRODUCT CODE · CLASS II

LPQ — Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 890.5870
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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