FDA 510(k)

Air Compression Massager (HY-1165)

Número K: K260529 · 2026-07-27

RequerenteXiamen High Top Electronic Technology Co., Ltd.

Data da decisão2026-07-27

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Air Compression Massager (HY-1165) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K260529. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Air Compression Massager (HY-1165)?

Air Compression Massager (HY-1165) is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. The 510(k) number is K260529.

When did Air Compression Massager (HY-1165) receive FDA 510(k) clearance?

Air Compression Massager (HY-1165) received FDA 510(k) clearance on 2026-07-27, under 510(k) number K260529.

Quem é o solicitante listado para o Massager de Compressão de Ar (HY-1165)?

The FDA 510(k) record lists Xiamen High Top Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Compression Massager (HY-1165)?

The FDA product code for Air Compression Massager (HY-1165) is IRP.

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Outros registros que listam Xiamen High Top Electronic Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: IRP)

K260944ManaCold Compression SystemManamed, LLC K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE Saúde K254200Massager de Perna de Compressão de Ar (Modelo: LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.K253064Sistema de Terapia de Pressão Ar (VU-IPC8M); Sistema de Terapia de Pressão Ar (VU-IPC6M); Sistema de Terapia de Pressão Ar (VU-IPC4X)Xiamen Weiyou Intelligent Technology Co., Ltd.

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