FDA 510(k)

生物波GO RX

K 號：K210202 · 2021-02-24

決定日期2021-02-24

產品代碼GZJ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

BioWaveGO RX is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K210202. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioWaveGO RX?

BioWaveGO RX is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Biowave Corporation. The 510(k) number is K210202.

When did BioWaveGO RX receive FDA 510(k) clearance?

BioWaveGO RX received FDA 510(k) clearance on 2021-02-24, under 510(k) number K210202.

Who is the listed applicant for BioWaveGO RX?

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

What is the FDA product code for BioWaveGO RX?

The FDA product code for BioWaveGO RX is GZJ.

其他以 Biowave Corporation 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。

K261522生物波生物包 K203158生物波生物包 K180943生物波GO

相關器械（代碼：GZJ）

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。

K252712STIMPOD NMS460 神經刺激器Algiamed Technologies USA, Inc.K252767actiTENS迷你版Sublimed K252236CP緩解棒Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046電氣神經肌肉刺激器，治療三合一Oriental Inspiration Limited

官方來源

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