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FDA 510(k)

Feather/numiere 05 06 07 (05)

K号: K253279 · 2025-12-24

申请人Heat IN A Click, LLC
决定日期2025-12-24
产品代码OHS
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Feather/numiere 05 06 07 (05) 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 2025-12-24 under 510(k) number K253279. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Feather/numiere 05 06 07 (05)?

Feather/numiere 05 06 07 (05) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K253279.

When did Feather/numiere 05 06 07 (05) receive FDA 510(k) clearance?

Feather/numiere 05 06 07 (05) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253279.

Who is the listed applicant for Feather/numiere 05 06 07 (05)?

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 Feather/numiere 05 06 07 (05)?

The FDA product code for Feather/numiere 05 06 07 (05) is OHS.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K251871FEATHER 01 02 03 04（型号：01）K214015Palm NRG 纤维瘤身体设备（型号：Palm NRG 身体设备）K202055Looper（型号：ZX-579S）K191938FitRelief TENS&EMS 无线设备

相关器械（代码：OHS）

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。

K260767面部美容设备（面部面膜LED美容设备A-901；面部LED & EMS美容设备A-902；面部面膜LED & EMS美容设备A-907）Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光疗面罩（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED光疗面罩（JML1，JML1+JML2）；LED光疗面罩（JML3，JML3+JML4）；LED光疗面罩（JML5，JML5+JML7）；LED光疗面罩（JML6，JML6+JML8）；LED光疗面罩（JML9，JML9+JML10）Shenzhen Qianyu Technology Co., Ltd.K261496LED光疗面罩（PE748，PE749，PE756）Duplex International Trading LimitedK261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）Led Intellectual Properties, LLC

官方来源

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