经皮神经电刺激（TENS）和电肌肉刺激器，TENS刺激器
K号: K183074 · 2020-01-11
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决定日期2020-01-11
产品代码IPF
咨询委员会PM
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决定实质等同
器械摘要
TENS and EMS Stimulator, TENS Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Astek Technology , Ltd.. It received FDA 510(k) clearance on 2020-01-11 under 510(k) number K183074. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TENS and EMS Stimulator, TENS Stimulator?
TENS and EMS Stimulator, TENS Stimulator is a medical device that received FDA 510(k) clearance on 2020-01-11. The listed applicant is Astek Technology , Ltd.. The 510(k) number is K183074.
When did TENS and EMS Stimulator, TENS Stimulator receive FDA 510(k) clearance?
TENS and EMS Stimulator, TENS Stimulator received FDA 510(k) clearance on 2020-01-11, under 510(k) number K183074.
Who is the listed applicant for TENS and EMS Stimulator, TENS Stimulator?
The FDA 510(k) record lists Astek Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TENS and EMS Stimulator, TENS Stimulator?
The FDA product code for TENS and EMS Stimulator, TENS Stimulator is IPF.
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：IPF）
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。
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