DeviceClearance

Product code OCF— Neurology

POLY-OP (TM)

Classification name
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code OCF under 21 CFR 882.5890, via openFDA

Market context for product code OCF

FDA has cleared 1 device under product code OCF, all in 1990, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OCF

Recent clearances under product code OCF

Data sourced from openFDA. This site is unofficial and independent of the FDA.