FDA 510(k)

Dispositivo de Terapia de Compressão de Ar, modelo: ST-502

Número K: K213745 · 2022-03-31

RequerenteShenzhen Future Electronic Co., Ltd.

Data da decisão2022-03-31

Código do produtoIRP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Air Compression Therapy Device, model: ST-502 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Future Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K213745. 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, model: ST-502?

Air Compression Therapy Device, model: ST-502 is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Shenzhen Future Electronic Co., Ltd.. The 510(k) number is K213745.

When did Air Compression Therapy Device, model: ST-502 receive FDA 510(k) clearance?

Air Compression Therapy Device, model: ST-502 received FDA 510(k) clearance on 2022-03-31, under 510(k) number K213745.

Who is the listed applicant for Air Compression Therapy Device, model: ST-502?

The FDA 510(k) record lists Shenzhen Future Electronic 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, model: ST-502?

The FDA product code for Air Compression Therapy Device, model: ST-502 is IRP.

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Outros registros que listam Shenzhen Future Electronic Co., Ltd. como candidato(a)

K251662Dispositivo de Terapia de Compressão de Ar (ST-504); Dispositivo de Terapia de Compressão de Ar (ST-505); Dispositivo de Terapia de Compressão de Ar (ST-506); Dispositivo de Terapia de Compressão de Ar (ST-507)K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304

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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