FDA 510(k)

PAT (Pain Alleviation Technologies)

Номер K: K182267 · 2019-02-27

Дата решения2019-02-27

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

PAT (Pain Alleviation Technologies) is the device name listed in this FDA 510(k) record. The listed applicant is Marchan Medical, LLC. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K182267. 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 PAT (Pain Alleviation Technologies)?

PAT (Pain Alleviation Technologies) is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Marchan Medical, LLC. The 510(k) number is K182267.

When did PAT (Pain Alleviation Technologies) receive FDA 510(k) clearance?

PAT (Pain Alleviation Technologies) received FDA 510(k) clearance on 2019-02-27, under 510(k) number K182267.

Who is the listed applicant for PAT (Pain Alleviation Technologies)?

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

What is the FDA product code for PAT (Pain Alleviation Technologies)?

The FDA product code for PAT (Pain Alleviation Technologies) 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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