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FDA 510(k)

Hand Massager (SM004D)

N.º K: K251622 · 2026-01-28

SolicitanteNingbo Zhenhai Yihao Electronic Technology Co., Ltd.
Fecha de decisión2026-01-28
Código de productoIRP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Hand Massager (SM004D) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251622. 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 Hand Massager (SM004D)?

Hand Massager (SM004D) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. The 510(k) number is K251622.

When did Hand Massager (SM004D) receive FDA 510(k) clearance?

Hand Massager (SM004D) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251622.

Who is the listed applicant for Hand Massager (SM004D)?

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

What is the FDA product code for Hand Massager (SM004D)?

The FDA product code for Hand Massager (SM004D) 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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