FDA 510(k)

Low-frequency Stimulator (Model: AST-645, AST-646)

N.º K: K212989 · 2021-11-22

SolicitanteShenzhen Osto Technology Co., Ltd.

Fecha de decisión2021-11-22

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Low-frequency Stimulator (Model: AST-645, AST-646) 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 2021-11-22 under 510(k) number K212989. 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 Low-frequency Stimulator (Model: AST-645, AST-646)?

Low-frequency Stimulator (Model: AST-645, AST-646) is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K212989.

When did Low-frequency Stimulator (Model: AST-645, AST-646) receive FDA 510(k) clearance?

Low-frequency Stimulator (Model: AST-645, AST-646) received FDA 510(k) clearance on 2021-11-22, under 510(k) number K212989.

Who is the listed applicant for Low-frequency Stimulator (Model: AST-645, AST-646)?

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 Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646) 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

K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)K172897Neck Care Therapy, Model: SYK 509B 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.