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FDA 510(k)

Cold/Hot Compression

K-Number: K223541 · 2023-10-27

ApplicantJkh Health Co., Ltd.
Decision Date2023-10-27
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Cold/Hot Compression is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under approval number K223541. 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 Cold/Hot Compression?

Cold/Hot Compression is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K223541.

When was Cold/Hot Compression approved by the FDA?

Cold/Hot Compression received FDA 510(k) clearance on 2023-10-27, under approval number K223541.

What company makes Cold/Hot Compression?

Cold/Hot Compression is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Cold/Hot Compression?

The FDA product code for Cold/Hot Compression is IRP.

Other Devices by Jkh Health Co., Ltd.

K153520Electronic Pulse Stimulator 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 K240986Cold 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.

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