FDA 510(k)

Digital TENS Unit

Номер K: K170145 · 2017-04-29

ЗаявительShenzhen Eapply Technology Co., Ltd.

Дата решения2017-04-29

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Digital TENS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Eapply Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-29 under 510(k) number K170145. 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 Digital TENS Unit?

Digital TENS Unit is a medical device that received FDA 510(k) clearance on 2017-04-29. The listed applicant is Shenzhen Eapply Technology Co., Ltd.. The 510(k) number is K170145.

When did Digital TENS Unit receive FDA 510(k) clearance?

Digital TENS Unit received FDA 510(k) clearance on 2017-04-29, under 510(k) number K170145.

Who is the listed applicant for Digital TENS Unit?

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

What is the FDA product code for Digital TENS Unit?

The FDA product code for Digital TENS Unit 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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