FDA 510(k)

Heat Pain Pro

Número K: K181992 · 2018-11-09

Data da decisão2018-11-09

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Heat Pain Pro is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181992. 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 Heat Pain Pro?

Heat Pain Pro is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K181992.

When did Heat Pain Pro receive FDA 510(k) clearance?

Heat Pain Pro received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181992.

Who is the listed applicant for Heat Pain Pro?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heat Pain Pro?

The FDA product code for Heat Pain Pro is NUH.

Outros registros que listam Omron Healthcare, Inc. como candidato(a)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)K202228Omron Model BP7900 Blood Pressure Monitor + EKG K183215Focus TENS Therapy, Model PM710-M/-L K190693HEM-6410T-ZL Wrist Blood Pressure Monitor K182579Omron Model BP7900 Blood Pressure Monitor + EKG K182120Maxpower Relief

Ver todos os 15 dispositivos →

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

Ver na base de dados da FDA →

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