FDA 510(k)

ALEVE_Direct_Therapy_(ALEVE_Direct_Therapy_TENS_Devise)

Номер K: K171802 · 2018-03-07

Дата решения2018-03-07

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K171802. 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 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K171802.

When did ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) receive FDA 510(k) clearance?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) received FDA 510(k) clearance on 2018-03-07, under 510(k) number K171802.

Who is the listed applicant for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

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

What is the FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

The FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) 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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