RelieforMe TENS/EMS 设备型号 UPK-GE01
K号: K192733 · 2019-12-23
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决定日期2019-12-23
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
RelieforMe TENS/EMS Device Model UPK-GE01 is the device name listed in this FDA 510(k) record. The listed applicant is Umeheal , Ltd.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K192733. 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 RelieforMe TENS/EMS Device Model UPK-GE01?
RelieforMe TENS/EMS Device Model UPK-GE01 is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Umeheal , Ltd.. The 510(k) number is K192733.
When did RelieforMe TENS/EMS Device Model UPK-GE01 receive FDA 510(k) clearance?
RelieforMe TENS/EMS Device Model UPK-GE01 received FDA 510(k) clearance on 2019-12-23, under 510(k) number K192733.
Who is the listed applicant for RelieforMe TENS/EMS Device Model UPK-GE01?
The FDA 510(k) record lists Umeheal , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01?
The FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01 is IPF.
相关临床试验
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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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