Is Shanghai Guanrui High Potential Therapy Machine a Class III medical device?

Yes

Manufacturing place No. 58, Tiandu Road, Pudong New Area, Shanghai

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Remarks

Registration No. State Food and Drug Administration Measures (Quasi) No. 3260002 of 2009

Manufacturing unit Shanghai Guanrui Medical Electronics Co. Highway

Postcode

Product Name High Potential Therapy Machine

Product Standard YZB/State 1409-2008 High Potential Therapy Machine

Product Performance Structure and Composition 1, High Potential Therapy Machine consists of the host computer, the application part (such as High Potential Therapy Pads, Warming Therapy Pads, Micro Patch, Therapy Pen) and the accessories (Checker, Remote Controller) components. 2, the main performance: 1) high potential, negative potential output voltage 0 ~ 9000V. can be set in steps (such as: 1000V, 3500V, 7000V, 9000V), with automatic changes in the output voltage with the time of the intelligent mode of operation and sleep mode of operation. 2) high-frequency frequency of the output of high-frequency wave for the 50kHz - 80kHz. 3) has a warm function. 4) with a Remote control function.3. Functions of each model: 1)GR-GDW-A: high potential, negative potential, high frequency, warm heat.2)GR-GDW-B: high potential, negative potential, high frequency.3)GR-GDW-C: high potential, negative potential.4)GR-GDW-C: high potential, negative potential.5)GR-GDW-C: high frequency, high frequency, high frequency.6)GR-GDW-C: high potential, negative potential. 7)GR-GDW-C: high potential, negative potential. 8)GR-GDW-C: high potential, negative potential. 9)GR-GDW-C: high potential, negative potential. 4)GR-GDW-D:High potential, warm heat.

Expiry date 2013.01.06

Approval date 2009.01.07

Product application scope Suitable for the treatment of neurasthenia.

Specifications GR-GDW-A, GR-GDW-B, GR-GDW-C, GR-GDW-D.

Accessories

Manufacturing place No. 58, Tiandu Road, Pudong New District, Shanghai

Change date

Remarks

Registration No. State Food and Drug Administration Mech (Quasi) No.2009 No. 3260354

Producer Shanghai Guanrui Medical Electronics Co. Structure and composition The treatment machine consists of the main body, electrode, warm far-infrared ray treatment pad, treatment pen, high voltage cable and accessories (checker, remote control) components. According to the different rated maximum output voltage and different combinations of functions (high potential, negative potential, high-frequency, warm far-infrared), it is divided into GR-GDW-30, GR-GDW-20, GR-GDW-09A, GR-GDW-09B, GR-GDW-09C, GR-GDW-09D.

Expiration date 2013.05.26

Approval Date 2009.05.27

Product Scope of Application It is suitable for the treatment of neurasthenia, insomnia, constipation, hypertension, diabetes mellitus, chronic fatigue syndrome.

Specification Model GR-GDW-30, GR-GDW-20, GR-GDW-09A, GR-GDW-09B, GR-GDW-09C, GR-GDW-09D

Accessory