FDA 510(k)

HBOTC Muscle and Nerve Stimulator

Номер K: K160255 · 2016-09-15

Дата решения2016-09-15

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

HBOTC Muscle and Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Hb Medical, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160255. 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 HBOTC Muscle and Nerve Stimulator?

HBOTC Muscle and Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Hb Medical, Inc.. The 510(k) number is K160255.

When did HBOTC Muscle and Nerve Stimulator receive FDA 510(k) clearance?

HBOTC Muscle and Nerve Stimulator received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160255.

Who is the listed applicant for HBOTC Muscle and Nerve Stimulator?

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

What is the FDA product code for HBOTC Muscle and Nerve Stimulator?

The FDA product code for HBOTC Muscle and Nerve Stimulator 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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