FDA 510(k)

電氣神經肌肉刺激器，治療三合一

K 號：K233046 · 2024-04-19

決定日期2024-04-19

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

Electrical Neuromuscular Stimulator, Cure Trio is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K233046. 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 Electrical Neuromuscular Stimulator, Cure Trio?

Electrical Neuromuscular Stimulator, Cure Trio is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K233046.

When did Electrical Neuromuscular Stimulator, Cure Trio receive FDA 510(k) clearance?

Electrical Neuromuscular Stimulator, Cure Trio received FDA 510(k) clearance on 2024-04-19, under 510(k) number K233046.

Who is the listed applicant for Electrical Neuromuscular Stimulator, Cure Trio?

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

What is the FDA product code for Electrical Neuromuscular Stimulator, Cure Trio?

The FDA product code for Electrical Neuromuscular Stimulator, Cure Trio is GZJ.

其他以 Oriental Inspiration Limited 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。

K213133Keffort (MC-100、MC-100A)K212285電氣神經肌肉刺激器（Cure Trio MC-310 iOS，Cure Trio MC-310 Android）K170269Hee HR Mini K170260BC-001+ 痤瘡淨化器

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 K222879經皮電神經刺激器（型號：TENS WMPS6-1）Wuxi Jiajian Medical Instrument Co., Ltd.

官方來源

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