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Product codes
OCF
Product code OCF
Device name
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Medical specialty
Neurology
Device class
2
Regulation number
882.5890
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
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).
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K900759
POLY-OP (TM)
Nu-Gyn-Tek, Inc.
1990-05-24