FDA 510(k)

RSHOCK

K 號：K220014 · 2023-03-01

決定日期2023-03-01

產品代碼PBX

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

RSHOCK is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K220014. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RSHOCK?

RSHOCK is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Swims America Corp. The 510(k) number is K220014.

When did RSHOCK receive FDA 510(k) clearance?

RSHOCK received FDA 510(k) clearance on 2023-03-01, under 510(k) number K220014.

Who is the listed applicant for RSHOCK?

The FDA 510(k) record lists Swims America Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RSHOCK?

The FDA product code for RSHOCK is PBX.

其他以 Swims America Corp 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。

K230167BACK 4 K230037BACK 3 K214090返回 3 颜色

相關器械（代碼：PBX）

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。

K243223多療法美容治療設備（BHS 202 UNYQUE）Bh Group Us, LLC K253480Capenergy C 裝置 RF C200 及 C400 DrakarianCapenergy Medical S.L.K260647規範化醫療設備名稱：SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV 裝置Pollogen, Ltd.

官方來源

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