FDA product code LPQ: Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
LPQ is the FDA product code for stimulator, ultrasound and muscle, for use other than applying therapeutic deep. It is a Class II device, regulated under 21 CFR 890.5870 and reviewed by the Orthopedic panel. Devices under LPQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for LPQ devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep |
| Device class | Class II |
| Regulation | 21 CFR 890.5870 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for LPQ devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-06-05.
Frequently asked questions
What is FDA product code LPQ?
LPQ is the FDA product code for stimulator, ultrasound and muscle, for use other than applying therapeutic deep. It is a Class II device, regulated under 21 CFR 890.5870 and reviewed by the Orthopedic panel.
What device class is LPQ?
Class II, regulation 21 CFR 890.5870. Typical premarket route: 510(k).
Have LPQ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2009-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LPQ
- Run a recall and safety report across every LPQ manufacturer
- Watch product code LPQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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