actiTENS迷你
K号: K252767 · 2026-01-16
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申请人Sublimed
决定日期2026-01-16
产品代码GZJ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Sublimed为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GZJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K252712STIMPOD NMS460 神经刺激器Algiamed Technologies USA, Inc.K252236CP 缓解 wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro（K-UNIPRO-US）Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046电神经肌肉刺激器，Cure TrioOriental Inspiration LimitedK222879经皮神经电刺激器（型号：TENS WMPS6-1）Wuxi Jiajian Medical Instrument Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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