FDA 510(k)

PlayMakar Sport Muscle Stimulator, Model PRO-500

Номер K: K182581 · 2018-11-21

Дата решения2018-11-21

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

PlayMakar Sport Muscle Stimulator, Model PRO-500 is the device name listed in this FDA 510(k) record. The listed applicant is Playmakar, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182581. 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 PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Playmakar, Inc.. The 510(k) number is K182581.

When did PlayMakar Sport Muscle Stimulator, Model PRO-500 receive FDA 510(k) clearance?

PlayMakar Sport Muscle Stimulator, Model PRO-500 received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182581.

Who is the listed applicant for PlayMakar Sport Muscle Stimulator, Model PRO-500?

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

What is the FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500 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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