# K253150: Cryon-X Cold Compression

- Pathway: 510(k) (Special)
- Applicant: Jkh Health Co., Ltd.
- Decided: Oct 24, 2025 after 29 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K881632 (1988). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223541: Cold/Hot Compression, Jkh Health Co., Ltd. (2023) Summary page 5.
- K193550: Therm-X, Zenith Technical Innovations (2020) Summary page 5.
- K143197: Nice1, Nice Recovery Systems, LLC (2014) Summary page 5.

## Indications for use
Cryon-X Pro The private-label Cryon-X Pro device combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) is indicated. The device may optionally provide DVT therapy, intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression. This device is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. Cryon-X One The private-label Cryon-X One device combines cold and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

Source page: https://510kreport.com/device/K253150
Methodology: https://510kreport.com/methodology