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FDA 510(k)

Cold/Hot Compression

K-Number: K223541 · 2023-10-27

Decision Date2023-10-27
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Cold/Hot Compression is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) 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. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K223541.

When did Cold/Hot Compression receive FDA 510(k) clearance?

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

Who is the listed applicant for Cold/Hot Compression?

The FDA 510(k) record lists Jkh Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Jkh Health Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.