Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

PlayMakar Sport Muscle Stimulator, Model PRO-500

N.º K: K182581 · 2018-11-21

SolicitantePlaymakar, Inc.
Fecha de decisión2018-11-21
Código de productoNUH
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

PlayMakar Sport Muscle Stimulator, Model PRO-500 is the device name listed in this FDA 510(k) record. The listed applicant is Playmakar, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182581. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Playmakar, Inc.. The 510(k) number is K182581.

When did PlayMakar Sport Muscle Stimulator, Model PRO-500 receive FDA 510(k) clearance?

PlayMakar Sport Muscle Stimulator, Model PRO-500 received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182581.

Who is the listed applicant for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA 510(k) record lists Playmakar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500 is NUH.

Ensayos clínicos relacionados

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.

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: NUH)

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.

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,LtdK260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑