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.
Interactive Rehabilitation Exercise Devices
Physical Medicine
Interactive Rehabilitation Exercise Devices (product code LXJ) are physical medicine instruments that use interactive technology, such as biofeedback or computer-assisted guidance, to facilitate therapeutic exercise and rehabilitation following injury or surgery. Regulated under 21 CFR 890.5360 and classified as a Class 2 device, they require a 510(k) premarket notification and fall under the Physical Medicine specialty. The devices are not flagged as implants or life-sustaining, and are not eligible for third-party review.
510(k) Clearances
27 matchesWhat 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.