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FDA 510(k)

冷壓-Cryon-X

K 號：K253150 · 2025-10-24

申請人Jkh Health Co., Ltd.
決定日期2025-10-24
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Cryon-X Cold 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 2025-10-24 under 510(k) number K253150. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K253150.

When did Cryon-X Cold Compression receive FDA 510(k) clearance?

Cryon-X Cold Compression received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253150.

Who is the listed applicant for Cryon-X Cold 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 Cryon-X Cold Compression?

The FDA product code for Cryon-X Cold Compression is IRP.

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相關器械（代碼：IRP）

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官方來源

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