Cryo-Thermo Compression Device (FGK002) (K222136)
Description
Cryo-Thermo Compression Device (FGK002) by Suzhou Microport Rehabtech (Group) Co., Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222136
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. Cryo-Thermo Compression Device (FGK002) (K222136) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193550 | Therm-X | Zenith Technical Innovations | 2020 |
| K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 |
Trace the full predicate network for K222136
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.