FDA 510(k)

羽絲/Numiere 05 06 07 (05)

K 號：K253279 · 2025-12-24

決定日期2025-12-24

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Feather/numiere 05 06 07 (05) is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click, LLC. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253279. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Feather/numiere 05 06 07 (05)?

Feather/numiere 05 06 07 (05) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K253279.

When did Feather/numiere 05 06 07 (05) receive FDA 510(k) clearance?

Feather/numiere 05 06 07 (05) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253279.

Who is the listed applicant for Feather/numiere 05 06 07 (05)?

The FDA 510(k) record lists Heat IN A Click, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Feather/numiere 05 06 07 (05)?

The FDA product code for Feather/numiere 05 06 07 (05) is OHS.

其他以 Heat IN A Click, LLC 為申請人之記錄

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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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