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FDA 510(k)

冷熱壓縮

K 號：K223541 · 2023-10-27

申請人Jkh Health Co., Ltd.
決定日期2023-10-27
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

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.

常見問題

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.

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其他以 Jkh Health Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：IRP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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