FDA 510(k)

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

N.º K: K233070 · 2024-03-13

SolicitanteChongqing Rob Linka Science and Technology Co., Ltd.

Fecha de decisión2024-03-13

Código de productoNGX

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K233070. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233070.

When did Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) receive FDA 510(k) clearance?

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233070.

Who is the listed applicant for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)?

The FDA product code for Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) is NGX.

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 Chongqing Rob Linka Science and Technology Co., Ltd. como solicitante

K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Dispositivos relacionados (Código: NGX)

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited K253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbH K252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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.