Is Shanghai Guanrui High Potential Therapeutic Apparatus a Class III Medical Device?

Place of production: No.58 Tiandu Road, Pudong New Area, Shanghai

change the date

comment

The registration number is US Food and Drug Administration (J) Zi 2009 No.3260002.

Shanghai guanrui medical electronics co., ltd.

Address: Zhufeng Highway, National Road 3 18, Zhujiajiao Town, Qingpu District, Shanghai.

postal code

Product name: high potential therapeutic instrument

Product standard YZB/ China 1409-2008 "high potential therapeutic machine"

Product performance, structure and composition 1. The high-potential therapeutic machine consists of a host, application parts (such as high-potential therapeutic pad, warm therapeutic pad, micro-patch, therapeutic pen) and accessories (electroscope, remote controller). 2. main performance: 1) high potential, negative potential output voltage 0 ~ 9000V v. It can be set in sections (such as 1000V, 3500V, 7000V, 9000V), with intelligent working mode and sleep working mode that automatically changes the output voltage with time. 2) The frequency of high frequency output is 50kHz-80kHz. 3) It has the function of heating. 4) It has remote control function. 3. Each model function: 1)GR-GDW-A: high potential, negative potential, high frequency and warm. 2)GR-GDW-B: high potential, negative potential and high frequency. 3)GR-GDW-C: high potential, negative potential. 4)GR-GDW-D: High potential and warm.

Validity: 20 13.438+0.06.

Date of approval: 2009.0 1.07

The product is suitable for the treatment of neurasthenia.

Specifications and models are GR-GDW-A, GR-GDW-B, GR-GDW-C and GR-GDW-D.

attachment

Place of production: No.58 Tiandu Road, Pudong New Area, Shanghai

change the date

comment

The country of registration is US Food and Drug Administration (J) Zi 2009 No.3260354.

Shanghai guanrui medical electronics co., ltd.

Address: Zhufeng Highway, National Road 3 18, Zhujiajiao Town, Qingpu District, Shanghai.

postal code

Product name: high potential therapeutic instrument

Product standard yzb/china0151-2009 "high potential therapeutic machine"

Product performance, structure and composition The therapeutic instrument consists of a host, electrodes, warm far-infrared therapeutic pads, therapeutic pens, high-voltage cables and accessories (detectors and remote controllers). According to the rated maximum output voltage, the function combinations are different (high potential, negative potential, high frequency, warm far infrared), which are divided into GR-GDW-30, GR-GDW-20, GR-GDW-09A, GR-GDW-09B, GR-GDW-09C and GR-GDW-09D.

Validity: 20 13.05.26

Date of ratification: 27 May 2009

The product is suitable for treating neurasthenia, insomnia, constipation, hypertension, diabetes and chronic fatigue syndrome.

Specifications and models are GR-GDW-30, GR-GDW-20, GR-GDW-09A, GR-GDW-09B, GR-GDW-09C and GR-GDW-09D.

attachment