Product code

QJQ: Cranial electrotherapy stimulator to treat insomnia and/or anxiety

FDA product code · Class II · Neurology

Key facts

Product code QJQ
Device Cranial electrotherapy stimulator to treat insomnia and/or anxiety
Device class Class II
Regulation number 882.5800
Review panel Neurology
Medical specialty Neurology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition To provide electrical current to the head to treat insomnia and/or anxiety

At a glance

  • 10–99 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 10–99 UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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