FDA 510(k)

Focus TENS Therapy, Model PM710-M/-L

N.º K: K183215 · 2019-09-07

Fecha de decisión2019-09-07

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Focus TENS Therapy, Model PM710-M/-L 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 2019-09-07 under 510(k) number K183215. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Focus TENS Therapy, Model PM710-M/-L?

Focus TENS Therapy, Model PM710-M/-L is a medical device that received FDA 510(k) clearance on 2019-09-07. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K183215.

When did Focus TENS Therapy, Model PM710-M/-L receive FDA 510(k) clearance?

Focus TENS Therapy, Model PM710-M/-L received FDA 510(k) clearance on 2019-09-07, under 510(k) number K183215.

Who is the listed applicant for Focus TENS Therapy, Model PM710-M/-L?

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 Focus TENS Therapy, Model PM710-M/-L?

The FDA product code for Focus TENS Therapy, Model PM710-M/-L is NUH.

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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

Fuente oficial

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