Class Class II
Coretech Compression System (Coretech RHB3003) (K250817)
Description
Coretech Compression System (Coretech RHB3003) by Vive Health, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250817
Clearance Date2025-08-08
Clearance TypeTraditional
Product CodeJOW
Regulation Number870.5800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250817
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. Coretech Compression System (Coretech RHB3003) (K250817) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022 |
| K201982 | Air compression therapy system FO-3001; Air compression the... | Foshan Hongfeng Co., Ltd. | 2021 |
| K123959 | CIRCUFLOW 5150 | Devon Medical, Inc. | 2013 |
Trace the full predicate network for K250817
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.