Product code

QPY: Stimulator, autonomic nerve, implanted for stroke rehabilitation

FDA product code · Class III · Physical Medicine

Key facts

Product code QPY
Device Stimulator, autonomic nerve, implanted for stroke rehabilitation
Device class Class III
Review panel Physical Medicine
Submission type PMA
GMP exempt No
Implanted device Yes
Life-sustaining or life-supporting No
Definition Stimulation of the vagus nerve

At a glance

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