510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900759Substantially Equivalent

Poly-Op (Tm)

Nu-Gyn-Tek, Inc., Oakfield NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900759 is the FDA 510(k) clearance record for POLY-OP (TM), a class II device, cleared for Nu-Gyn-Tek, Inc. on under FDA product code OCF (Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief). FDA's definition for product code OCF 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)". FDA records list 2 510(k) clearances for Nu-Gyn-Tek, Inc., from to . As of , FDA records show no recalls naming K900759.

Clearance record

Decision date
Received
(97 days to decision)
Product code
OCF Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Nu-Gyn-Tek, Inc. P.O. Box 75, Oakfield NY
Third party review
No

Clearances, product code OCF

Trailing 12 months

FDA records hold no clearances under product code OCF in the trailing twelve months.

FDA records show no clearances under product code OCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260