FDA 510(k)

GIM-STIM OTC TENS/EMS System

Номер K: K190988 · 2019-08-16

Дата решения2019-08-16

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

GIM-STIM OTC TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K190988. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the GIM-STIM OTC TENS/EMS System?

GIM-STIM OTC TENS/EMS System is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K190988.

When did GIM-STIM OTC TENS/EMS System receive FDA 510(k) clearance?

GIM-STIM OTC TENS/EMS System received FDA 510(k) clearance on 2019-08-16, under 510(k) number K190988.

Who is the listed applicant for GIM-STIM OTC TENS/EMS System?

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

What is the FDA product code for GIM-STIM OTC TENS/EMS System?

The FDA product code for GIM-STIM OTC TENS/EMS System is NUH.

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: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Официальный источник

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