FDA 510(k)

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

Номер K: K221199 · 2023-12-19

ЗаявительGreen Island International Tcm Group Limited

Дата решения2023-12-19

Код продуктаGXY

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is the device name listed in this FDA 510(k) record. The listed applicant is Green Island International Tcm Group Limited. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K221199. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Green Island International Tcm Group Limited. The 510(k) number is K221199.

When did Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) receive FDA 510(k) clearance?

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) received FDA 510(k) clearance on 2023-12-19, under 510(k) number K221199.

Who is the listed applicant for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

The FDA 510(k) record lists Green Island International Tcm Group Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)?

The FDA product code for Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) is GXY.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Cup MRI/CT (Модели 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Модели 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Модели 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

Официальный источник

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