HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (K213655)
Description
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) by Hilltek, LLC, an FDA 510(k) cleared physical medicine device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213655
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (K213655) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K113017 | SYS*STIM 240 | Mettler Electronics Corp. | 2012 |
Trace the full predicate network for K213655
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.