FDA 510(k)

actiTENS迷你版

K 號：K252767 · 2026-01-16

決定日期2026-01-16

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

actiTENS mini is the device name listed in this FDA 510(k) record. The listed applicant is Sublimed. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252767. 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 actiTENS mini?

actiTENS mini is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Sublimed. The 510(k) number is K252767.

When did actiTENS mini receive FDA 510(k) clearance?

actiTENS mini received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252767.

Who is the listed applicant for actiTENS mini?

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

What is the FDA product code for actiTENS mini?

The FDA product code for actiTENS mini is GZJ.

其他以 Sublimed 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。

K202159行動電擊療法器

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.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 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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