Product code

OCF: Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief

FDA product code · Class II · Neurology

Key facts

Product code OCF
Device Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
Device class Class II
Regulation number 882.5890
Review panel Neurology
Medical specialty Neurology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None 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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