FDA 510(k)

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

Número K: K252154 · 2025-12-09

RequerenteGuangzhou Longest Medical Technology Co., Ltd.

Data da decisão2025-12-09

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K252154. 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 Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. The 510(k) number is K252154.

When did Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) receive FDA 510(k) clearance?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) received FDA 510(k) clearance on 2025-12-09, under 510(k) number K252154.

Who is the listed applicant for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

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

What is the FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

The FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) 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 Guangzhou Longest Medical Technology Co., Ltd. como candidato(a)

K250242Compression Therapy Device (LGT-2202DVT)K250244Compression Therapy Device (LGT-2210DS)

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 K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.K251594truFlexSyrma Johari Medtech Limited

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.