FDA 510(k)

TENS & PMS Unit

Número K: K220005 · 2022-04-01

RequerenteShenzhen Yuehua Xinsen Technology Co., Ltd.

Data da decisão2022-04-01

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS & PMS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yuehua Xinsen Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K220005. 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 & PMS Unit?

TENS & PMS Unit is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Shenzhen Yuehua Xinsen Technology Co., Ltd.. The 510(k) number is K220005.

When did TENS & PMS Unit receive FDA 510(k) clearance?

TENS & PMS Unit received FDA 510(k) clearance on 2022-04-01, under 510(k) number K220005.

Who is the listed applicant for TENS & PMS Unit?

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

What is the FDA product code for TENS & PMS Unit?

The FDA product code for TENS & PMS Unit is NUH.

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.,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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.