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FDA PMA

Stimulator, bone growth, non-invasive

PMA Number: P190030 · 2026-05-13

ApplicantTheragen, Inc.
Decision Date2026-05-13
PMA NumberP190030
Product CodeLOF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Stimulator, bone growth, non-invasive is a medical device manufactured by Theragen, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-13 under PMA number P190030. The device is classified under FDA product code LOF. It was reviewed by the OR advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Stimulator, bone growth, non-invasive?

Stimulator, bone growth, non-invasive is a medical device that received FDA Premarket Approval (PMA) on 2026-05-13. It is manufactured by Theragen, Inc.. The PMA number is P190030.

When did Stimulator, bone growth, non-invasive receive FDA PMA approval?

Stimulator, bone growth, non-invasive received FDA PMA approval on 2026-05-13, under approval number P190030.

What company makes Stimulator, bone growth, non-invasive?

Stimulator, bone growth, non-invasive is manufactured by Theragen, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Stimulator, bone growth, non-invasive?

The FDA product code for Stimulator, bone growth, non-invasive is LOF.

What FDA device class is Stimulator, bone growth, non-invasive?

Stimulator, bone growth, non-invasive is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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