# K240986: Cold Compression

- Pathway: 510(k) (Special)
- Applicant: Jkh Health Co., Ltd.
- Decided: May 1, 2024 after 21 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.
- K183702: Polar Care Wave, Breg, Inc. (2019) Summary page 5.

## Indications for use
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. Cold Compression 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/K240986
Methodology: https://510kreport.com/methodology