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.
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Physical Medicine
A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a physical medicine device that can be programmed to apply electrical current via skin-surface electrodes placed over the spine, intended to improve muscle strength and sensation in patients following neurological deficit, leveraging spinal cord stimulation pathways. It is classified as FDA Class II (510(k) required) under regulation 890.5851 in the Physical Medicine specialty, with product code SDO. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
4 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.