FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (9029SCM)

Номер K: K240292 · 2024-03-25

Дата решения2024-03-25

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Transcutaneous Electrical Nerve Stimulator (9029SCM) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Kong Etech Groups Limited. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K240292. 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 Transcutaneous Electrical Nerve Stimulator (9029SCM)?

Transcutaneous Electrical Nerve Stimulator (9029SCM) is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Hong Kong Etech Groups Limited. The 510(k) number is K240292.

When did Transcutaneous Electrical Nerve Stimulator (9029SCM) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (9029SCM) received FDA 510(k) clearance on 2024-03-25, under 510(k) number K240292.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (9029SCM)?

The FDA 510(k) record lists Hong Kong Etech Groups Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (9029SCM)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (9029SCM) 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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