FDA 510(k)

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)

Número K: K201845 · 2020-10-08

RequerenteGuangzhou Longest Science & Technology Co., Ltd.

Data da decisão2020-10-08

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K201845. 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, Model: LGT-232(US)?

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K201845.

When did Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) receive FDA 510(k) clearance?

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201845.

Who is the listed applicant for Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)?

The FDA 510(k) record lists Guangzhou Longest Science & 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, Model: LGT-232(US)?

The FDA product code for Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) is NGX.

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Outros registros que listam Guangzhou Longest Science & Technology Co., Ltd. como candidato(a)

K202110MStim Drop Model: LGT-233 K182020Portable Electro-Stimulation Therapy Device K191856Compression Therapy Device K191862Compression Therapy Device Model LGT-2200SP K182108Portable Electro-Stimulation Therapy Device

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

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