Class Class II
CoolTone (K251378)
Description
CoolTone by Zimmer Medizinsysteme GmbH, an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251378
Clearance Date2025-07-14
Clearance TypeSpecial
Product CodeNGX
Regulation Number890.5850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251378
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. CoolTone (K251378) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220601 | CoolTone | Zimmer Medizinsysteme GmbH | 2022 |
Trace the full predicate network for K251378
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.