Data da decisão2019-11-01
Código do produtoNUH
Comité consultivoNE
DecisãoSubstantially Equivalent
Resumo do dispositivo
Combo Electrotherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K192087. 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 Combo Electrotherapy Device?
Combo Electrotherapy Device is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K192087.
When did Combo Electrotherapy Device receive FDA 510(k) clearance?
Combo Electrotherapy Device received FDA 510(k) clearance on 2019-11-01, under 510(k) number K192087.
Who is the listed applicant for Combo Electrotherapy Device?
The FDA 510(k) record lists Shenzhen Roundwhale Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Combo Electrotherapy Device?
The FDA product code for Combo Electrotherapy Device is NUH.
Ensaios clínicos relacionados
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Outros registros que listam Shenzhen Roundwhale Technology Co. , Ltd. como candidato(a)
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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
Fonte oficial
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