iRelieve 微电流疼痛缓解系统
K号: K212618 · 2022-09-14
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决定日期2022-09-14
产品代码GZJ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
iRelieve Microcurrent Pain Relief System is the device name listed in this FDA 510(k) record. The listed applicant is Fast Track Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K212618. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iRelieve Microcurrent Pain Relief System?
iRelieve Microcurrent Pain Relief System is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Fast Track Technologies, Inc.. The 510(k) number is K212618.
When did iRelieve Microcurrent Pain Relief System receive FDA 510(k) clearance?
iRelieve Microcurrent Pain Relief System received FDA 510(k) clearance on 2022-09-14, under 510(k) number K212618.
Who is the listed applicant for iRelieve Microcurrent Pain Relief System?
The FDA 510(k) record lists Fast Track Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iRelieve Microcurrent Pain Relief System?
The FDA product code for iRelieve Microcurrent Pain Relief System is GZJ.
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相关器械（代码：GZJ）
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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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