免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

BionicGym Powered Muscle Stimulator

K号: K182794 · 2019-07-18

决定日期2019-07-18
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

BionicGym Powered Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Medical Currents, Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K182794. 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 BionicGym Powered Muscle Stimulator?

BionicGym Powered Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Medical Currents, Ltd.. The 510(k) number is K182794.

When did BionicGym Powered Muscle Stimulator receive FDA 510(k) clearance?

BionicGym Powered Muscle Stimulator received FDA 510(k) clearance on 2019-07-18, under 510(k) number K182794.

Who is the listed applicant for BionicGym Powered Muscle Stimulator?

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

What is the FDA product code for BionicGym Powered Muscle Stimulator?

The FDA product code for BionicGym Powered Muscle Stimulator is NGX.

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。

相关器械(代码:NGX)

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。

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。

↑