FDA 510(k)

Pixie Pulse (SM9068)

Номер K: K241365 · 2024-08-12

Дата решения2024-08-12

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Pixie Pulse (SM9068) is the device name listed in this FDA 510(k) record. The listed applicant is Pixie Cup, LLC. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241365. 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 Pixie Pulse (SM9068)?

Pixie Pulse (SM9068) is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Pixie Cup, LLC. The 510(k) number is K241365.

When did Pixie Pulse (SM9068) receive FDA 510(k) clearance?

Pixie Pulse (SM9068) received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241365.

Who is the listed applicant for Pixie Pulse (SM9068)?

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

What is the FDA product code for Pixie Pulse (SM9068)?

The FDA product code for Pixie Pulse (SM9068) 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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