510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
Physical Medicine
The Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation (product code NYY) is a powered electrical muscle stimulation device used for rehabilitation purposes, including relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and prevention of venous thrombosis following surgery. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 890.5850 within the Physical Medicine specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.
No 510(k) clearances found for "NYY". Try a different K-number, product code, or device name.
What is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.