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FDA 510(k)

Cryo-Thermo Compression Device (FGK002)

N.º K: K222136 · 2023-03-08

SolicitanteSuzhou Microport Rehabtech (Group) Co., Ltd.
Fecha de decisión2023-03-08
Código de productoIRP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cryo-Thermo Compression Device (FGK002) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K222136. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cryo-Thermo Compression Device (FGK002)?

Cryo-Thermo Compression Device (FGK002) is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. The 510(k) number is K222136.

When did Cryo-Thermo Compression Device (FGK002) receive FDA 510(k) clearance?

Cryo-Thermo Compression Device (FGK002) received FDA 510(k) clearance on 2023-03-08, under 510(k) number K222136.

Who is the listed applicant for Cryo-Thermo Compression Device (FGK002)?

The FDA 510(k) record lists Suzhou Microport Rehabtech (Group) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryo-Thermo Compression Device (FGK002)?

The FDA product code for Cryo-Thermo Compression Device (FGK002) is IRP.

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Dispositivos relacionados (Código: IRP)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260944ManaCold Compression SystemManamed, LLCK260529Air 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 SaúdeK254200Masajeador de Piernas de Compresión Aérea (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.

Fuente oficial

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