FDA 510(k)

體型雕塑機（型號：CS2、CS3、CS5、CS7、CS8、CS11、CS13）

K 號：K232181 · 2024-04-24

決定日期2024-04-24

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei JT Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K232181. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Hebei JT Medical Co., Ltd.. The 510(k) number is K232181.

When did Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) receive FDA 510(k) clearance?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K232181.

Who is the listed applicant for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

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

What is the FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

The FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is NGX.

其他以 Hebei JT Medical Co., Ltd. 為申請人之記錄

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相關器械（代碼：NGX）

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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