FDA 510(k)

Quell

Номер K: K152954 · 2016-01-05

Дата решения2016-01-05

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Quell is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152954. 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 Quell?

Quell is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is Neurometrix, Inc.. The 510(k) number is K152954.

When did Quell receive FDA 510(k) clearance?

Quell received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152954.

Who is the listed applicant for Quell?

The FDA 510(k) record lists Neurometrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quell?

The FDA product code for Quell 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.

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

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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