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FDA 510(k)

動力式充氣管壓力按摩器 - 精緻上昇排汗器

K 號：K201730 · 2022-08-22

申請人Foggiare Technologies, LLC
決定日期2022-08-22
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Powered Inflatable Tube Massager - SLIM UP DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Foggiare Technologies, LLC. It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K201730. 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 Powered Inflatable Tube Massager - SLIM UP DRAIN?

Powered Inflatable Tube Massager - SLIM UP DRAIN is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Foggiare Technologies, LLC. The 510(k) number is K201730.

When did Powered Inflatable Tube Massager - SLIM UP DRAIN receive FDA 510(k) clearance?

Powered Inflatable Tube Massager - SLIM UP DRAIN received FDA 510(k) clearance on 2022-08-22, under 510(k) number K201730.

Who is the listed applicant for Powered Inflatable Tube Massager - SLIM UP DRAIN?

The FDA 510(k) record lists Foggiare Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Inflatable Tube Massager - SLIM UP DRAIN?

The FDA product code for Powered Inflatable Tube Massager - SLIM UP DRAIN is IRP.

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。

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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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