Product code

QSQ: Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms

FDA product code · Class II · Neurology

Key facts

Product code QSQ
Device Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms
Device class Class II
Regulation number 882.5888
Review panel Neurology
Medical specialty Neurology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.

At a glance

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