FDA 510(k)

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

K号: K233070 · 2024-03-13

申请人Chongqing Rob Linka Science and Technology Co., Ltd.

决定日期2024-03-13

产品代码NGX

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K233070. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233070.

When did Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) receive FDA 510(k) clearance?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233070.

Who is the listed applicant for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is NGX.

列明Chongqing Rob Linka Science and Technology Co., Ltd.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。

K233067无线经皮神经电刺激（TENS）与电肌肉刺激（EMS）（型号SM9110，SM9113，SM9116）K233092疼痛治疗设备（SM9075，SM9910，SM9067，SM9587W）K230829TENS7000可充电式（型号：TENS7000可充电式）

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