OCF — Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief Class II

FDA Device Classification

FDA product code OCF covers "Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
OCF
Device Class
Class II
Regulation Number
882.5890
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K900759nu-gyn-tekPOLY-OP (TM)May 24, 1990