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LPQClass II

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

21 CFR 890.5870 / Orthopedic
FDA source (opens on fda.gov)

LPQ is the FDA product code for Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep, a class II device type, regulated under 21 CFR 890.5870. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
LPQ
Device name
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA 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
21 CFR 890.5870
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code