FDA 510(k)

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)

Número K: K232181 · 2024-04-24

Data da decisão2024-04-24

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei JT Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K232181. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Hebei JT Medical Co., Ltd.. The 510(k) number is K232181.

When did Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) receive FDA 510(k) clearance?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K232181.

Who is the listed applicant for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

The FDA 510(k) record lists Hebei JT Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

The FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is NGX.

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_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

Outros registros que listam Hebei JT Medical Co., Ltd. como candidato(a)

K250722Nd: YAG Laser Therapy System (QN-1)K240658máquina de emagrecimento com corpo a laser de 1060nm

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.

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.