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OCFClass II

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

21 CFR 882.5890 / Neurology

OCF is the FDA product code for Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief, a class II device type, regulated under 21 CFR 882.5890. FDA's definition for this code reads: "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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OCF
Device name
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
FDA 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).
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OCF

By decision year
1 clearance under product code OCF with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCF by decision year
YearClearances
19901

Applicants with the most clearances

Product code OCF
Applicants holding the most 510(k) clearances under product code OCF
ApplicantClearances
Nu-Gyn-Tek, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OCF.