FDA 510(k)

Neck Care Therapy, Model: SYK 509B

N.º K: K172897 · 2018-12-07

SolicitanteShenzhen Osto Technology Co., Ltd.

Fecha de decisión2018-12-07

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Neck Care Therapy, Model: SYK 509B is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K172897. 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 Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172897.

When did Neck Care Therapy, Model: SYK 509B receive FDA 510(k) clearance?

Neck Care Therapy, Model: SYK 509B received FDA 510(k) clearance on 2018-12-07, under 510(k) number K172897.

Who is the listed applicant for Neck Care Therapy, Model: SYK 509B?

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

What is the FDA product code for Neck Care Therapy, Model: SYK 509B?

The FDA product code for Neck Care Therapy, Model: SYK 509B 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Shenzhen Osto Technology Co., Ltd. como solicitante

K212989Low-frequency Stimulator (Model: AST-645, AST-646)K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)K172837Low-frequency Multi-function physiotherapy instrument K172834Dual output digital therapy massager

Dispositivos relacionados (Código: NUH)

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.,Ltd K260412TENS 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.