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FDA 510(k)

TENS&EMS units (SM9109A, SM9109B)

Número K: K241509 · 2024-06-27

RequerentePlexus Yoga, LLC Dba Chirp
Data da decisão2024-06-27
Código do produtoNUH
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS&EMS units (SM9109A, SM9109B) is the device name listed in this FDA 510(k) record. The listed applicant is Plexus Yoga, LLC Dba Chirp. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K241509. 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 TENS&EMS units (SM9109A, SM9109B)?

TENS&EMS units (SM9109A, SM9109B) is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Plexus Yoga, LLC Dba Chirp. The 510(k) number is K241509.

When did TENS&EMS units (SM9109A, SM9109B) receive FDA 510(k) clearance?

TENS&EMS units (SM9109A, SM9109B) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241509.

Who is the listed applicant for TENS&EMS units (SM9109A, SM9109B)?

The FDA 510(k) record lists Plexus Yoga, LLC Dba Chirp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS&EMS units (SM9109A, SM9109B)?

The FDA product code for TENS&EMS units (SM9109A, SM9109B) is NUH.

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Dispositivos Relacionados (Código: NUH)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.,LtdK260412TENS 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

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