FDA 510(k)

Muscle Stimulator

Número K: K231648 · 2024-03-01

RequerenteShenzhen Yiran Intelligent Co., Ltd.

Data da decisão2024-03-01

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yiran Intelligent Co., Ltd.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K231648. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Muscle Stimulator?

Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Shenzhen Yiran Intelligent Co., Ltd.. The 510(k) number is K231648.

When did Muscle Stimulator receive FDA 510(k) clearance?

Muscle Stimulator received FDA 510(k) clearance on 2024-03-01, under 510(k) number K231648.

Who is the listed applicant for Muscle Stimulator?

The FDA 510(k) record lists Shenzhen Yiran Intelligent Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Muscle Stimulator?

The FDA product code for Muscle Stimulator is NUH.

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Literatura relacionada no PubMed

PMID: 30799667Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.The Journal of dermatological treatment ()

Dispositivos Relacionados (Código: 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

Fonte oficial

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