FDA 510(k)

AffloVest® 移動氣道清除治療

K 號：K252849 · 2026-04-30

決定日期2026-04-30

產品代碼BYI

諮詢委員會AN

決定相當於

器材摘要

AffloVest® Mobile Airway Clearance Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Medical. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K252849. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AffloVest® Mobile Airway Clearance Therapy?

AffloVest® Mobile Airway Clearance Therapy is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Tactile Medical. The 510(k) number is K252849.

When did AffloVest® Mobile Airway Clearance Therapy receive FDA 510(k) clearance?

AffloVest® Mobile Airway Clearance Therapy received FDA 510(k) clearance on 2026-04-30, under 510(k) number K252849.

Who is the listed applicant for AffloVest® Mobile Airway Clearance Therapy?

FDA 510(k) 記錄將 Tactile Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AffloVest® Mobile Airway Clearance Therapy?

The FDA product code for AffloVest® Mobile Airway Clearance Therapy is BYI.

其他以 Tactile Medical 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。

K253555Flexitouch® Plus 進階氣動壓迫系統 K234155Nimbl (型號 PD08-N1)

相關器械（代碼：BYI）

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。

K250860BreatheBand®（型號 1000）Exemplar Medical, LLC K242063LibAirty 氣道清除系統Synchrony Medical , Ltd.K240959呼吸肌肉訓練器Chongqing Moffy Innovation Technology Co., Ltd.K233441Vest APX 系統（PVAPX1）Baxter Healthcare Corportation K222496Electromed SmartVest 氣道清除系統Electromed, Inc.K201490電流浮動6呼吸道清潔系統Med Systems, Inc.

官方來源

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