Cleared Traditional

POLY-OP (TM) (K900759) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900759 · Nu-Gyn-Tek, Inc. · Neurology device
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May 1990
Decision
97d
Days
Class 2
Risk

K900759 is an FDA 510(k) clearance for the POLY-OP (TM). Classified as Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief (product code OCF), Class II - Special Controls.

Submitted by Nu-Gyn-Tek, Inc. (Oakfield, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nu-Gyn-Tek, Inc. devices

Submission Details

510(k) Number K900759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date May 24, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 148d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCF Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.