Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Leg and Foot Air Wave Pressure Therapy Device

Número K: K223464 · 2023-03-14

RequerenteZhangzhou Easepal Innovation CO , Ltd.
Data da decisão2023-03-14
Código do produtoIRP
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Leg and Foot Air Wave Pressure Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Zhangzhou Easepal Innovation CO , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223464. 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 Leg and Foot Air Wave Pressure Therapy Device?

Leg and Foot Air Wave Pressure Therapy Device is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Zhangzhou Easepal Innovation CO , Ltd.. The 510(k) number is K223464.

When did Leg and Foot Air Wave Pressure Therapy Device receive FDA 510(k) clearance?

Leg and Foot Air Wave Pressure Therapy Device received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223464.

Who is the listed applicant for Leg and Foot Air Wave Pressure Therapy Device?

The FDA 510(k) record lists Zhangzhou Easepal Innovation CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leg and Foot Air Wave Pressure Therapy Device?

The FDA product code for Leg and Foot Air Wave Pressure Therapy Device is IRP.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: IRP)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 SaúdeK254200Massager 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑