FDA 510(k)

Dispositivo de Terapia de Compressão de Ar (K1002/K1006/K1007/K1008/K1061)

Número K: K251623 · 2025-09-17

RequerenteShenzhen Yicai Health Technology Co., Ltd.

Data da decisão2025-09-17

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251623. 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 Therapy Device (K1002/K1006/K1007/K1008/K1061)?

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. The 510(k) number is K251623.

When did Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) receive FDA 510(k) clearance?

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251623.

Who is the listed applicant for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?

The FDA 510(k) record lists Shenzhen Yicai Health Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?

The FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is IRP.

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Outros registros que listam Shenzhen Yicai Health Technology Co., Ltd. como candidato(a)

K250784Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)K241119Transcutaneous Electrical Nerve Stimulator (K6106)

Dispositivos Relacionados (Código: IRP)

K260944ManaCold Compression SystemManamed, LLC K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.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.

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