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FDA 510(k)

AGILIS - 多功能物理治療臺（型號：Plus，Pro和Basic）

K 號：K241193 · 2025-01-31

申請人Marzzan Lucas Jorge
決定日期2025-01-31
產品代碼JFB
諮詢委員會PM
決定相當於

器材摘要

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) is the device name listed in this FDA 510(k) record. The listed applicant is Marzzan Lucas Jorge. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K241193. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)?

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Marzzan Lucas Jorge. The 510(k) number is K241193.

When did AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) receive FDA 510(k) clearance?

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) received FDA 510(k) clearance on 2025-01-31, under 510(k) number K241193.

Who is the listed applicant for AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)?

The FDA 510(k) record lists Marzzan Lucas Jorge as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)?

The FDA product code for AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) is JFB.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：JFB）

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。

K250266瓷療自動熱按摩器（CGM MB-2401）Ceragem Co., Ltd.K243644瓷療自動熱療按摩器（CGM MB-2301 & CGM MB-2302）Ceragem Co., Ltd.K243355瓷療自動熱按摩器（CGM-MB-1902）Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572瓷療自動熱療按摩器，型號 CGM MB-1701 及 CGM MB-1702Ceragem Co., Ltd.K202937瓷療自動熱按摩器型號 CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd.

官方來源

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