Cryon-X Cold Compression
K-Number: K253150 · 2025-10-24
ApplicantJkh Health Co., Ltd.
Decision Date2025-10-24
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Cryon-X Cold Compression is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2025-10-24 under approval number K253150. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cryon-X Cold Compression?
Cryon-X Cold Compression is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K253150.
When was Cryon-X Cold Compression approved by the FDA?
Cryon-X Cold Compression received FDA 510(k) clearance on 2025-10-24, under approval number K253150.
What company makes Cryon-X Cold Compression?
Cryon-X Cold Compression is manufactured by Jkh Health Co., Ltd..
What is the FDA product code for Cryon-X Cold Compression?
The FDA product code for Cryon-X Cold Compression is IRP.
Other Devices by Jkh Health Co., Ltd.
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K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K200561StimPlus Patch, StimPlus Patch, StimPlus Patch
K202839Overlapped Compression Therapy
K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
K223541Cold/Hot Compression
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.