FitRelief TENS&EMS 无线设备
K号: K191938 · 2020-08-28
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决定日期2020-08-28
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
FitRelief TENS&EMS Wireless Device is the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click, LLC. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K191938. 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 FitRelief TENS&EMS Wireless Device?
FitRelief TENS&EMS Wireless Device is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K191938.
When did FitRelief TENS&EMS Wireless Device receive FDA 510(k) clearance?
FitRelief TENS&EMS Wireless Device received FDA 510(k) clearance on 2020-08-28, under 510(k) number K191938.
Who is the listed applicant for FitRelief TENS&EMS Wireless Device?
The FDA 510(k) record lists Heat IN A Click, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FitRelief TENS&EMS Wireless Device?
The FDA product code for FitRelief TENS&EMS Wireless Device is NGX.
相关临床试验
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列明Heat IN A Click, LLC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：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。
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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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