FDA product code SHX: Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms

SHX is the FDA product code for transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms. It is a Class II device, regulated under 21 CFR 882.5807 and reviewed by the Neurology panel. Devices under SHX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment.

Classification

Recalls for SHX devices

openFDA lists no recalls for product code SHX.

Frequently asked questions

What is FDA product code SHX?

SHX is the FDA product code for transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms. It is a Class II device, regulated under 21 CFR 882.5807 and reviewed by the Neurology panel.

What device class is SHX?

Class II, regulation 21 CFR 882.5807. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SHX
• Run a recall and safety report across every SHX manufacturer
• Watch product code SHX 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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