510(k) Report

FDA product code · Neurology

Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

OCFClass II21 CFR 882.5890510(k) required1 decision since 19900 recalls

1 FDA decision since 1990. No recall names this code.

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).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of OCF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OCF

FDA has decided no OCF device since 2007.

Median 510(k) review, days · OCF

Too few OCF 510(k)s in any year since 2007 to give a median.

Recalls per year · OCF

No recall names OCF since 2007.

Adverse event reports per year · OCF

No MAUDE report names OCF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OCF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OCF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 882.5890.