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FDA 510(k)

ALEVE Terapia Direta (Dispositivo de TENS ALEVE Direct Therapy)

Número K: K171802 · 2018-03-07

RequerenteBayer Healthcare, LLC
Data da decisão2018-03-07
Código do produtoNUH
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: NUH)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.,LtdK260412TENS 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

Fonte oficial

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