FDA 510(k)

Nu-beca Transcutaneous Electrical Nerve Stimulation

Номер K: K223151 · 2023-07-19

Дата решения2023-07-19

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Nu-beca Transcutaneous Electrical Nerve Stimulation is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Beca & Maxcellent Co.. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K223151. 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 Nu-beca Transcutaneous Electrical Nerve Stimulation?

Nu-beca Transcutaneous Electrical Nerve Stimulation is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Nu-Beca & Maxcellent Co.. The 510(k) number is K223151.

When did Nu-beca Transcutaneous Electrical Nerve Stimulation receive FDA 510(k) clearance?

Nu-beca Transcutaneous Electrical Nerve Stimulation received FDA 510(k) clearance on 2023-07-19, under 510(k) number K223151.

Who is the listed applicant for Nu-beca Transcutaneous Electrical Nerve Stimulation?

The FDA 510(k) record lists Nu-Beca & Maxcellent Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nu-beca Transcutaneous Electrical Nerve Stimulation?

The FDA product code for Nu-beca Transcutaneous Electrical Nerve Stimulation 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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