Reduced-Electron Therapy Device

What is a Redox Therapy Device?

"Reduced-Electron Therapy Device" is a general term for equipment used to perform Reduced-Electron Therapy®, and is Reltech's internal designation.

Redox Electron Therapy® refers to the “Transdermal Electron Supplementation Therapy” discovered and proposed by Dr . Yutaka Horiguchi, Director ofHoriguchi Clinic, part of the Kenshokai Medical Corporation. The Kenshokai Medical Corporation holds the trademark rights for this treatment, which is registered under Class 44: “Medical services; provision of medical information.”

The electron-reduction therapy device is equipped with a transdermal electron delivery function that utilizes microcurrent and negative high voltage, among other technologies, and has undergone continuous refinement over a period of more than 20 years.

Two Types of Reduced-Electron Therapy Devices

There are two typesof electron-reduction therapy devices: (1) those classified as medical devices for healthcare professionals, and (2) those classified as electron generators.

(1) A reduction electron therapy device classified as a medical device for healthcare professionals

"Medical devices for physicians" refers to medical devices that may be used by a patient only when a physician has diagnosed the patient and determined that treatment with the device is necessary.

Redox therapy devices, which are classified as medical devices for healthcare professionals, have two functions: transcutaneouselectron deliveryand negative potential therapy. It isthe negative potential therapy functionthat classifies these devices asmedicaldevices. This function is achieved not by the structure or components of the device itself, but by an insulated mat—an accessory—that isolates the human body from the ground (see [Reference] Standards for Potential Therapy Devices ).

(2) Reductive electron therapy devices classified as electron generators

The electron supply device is a reduction electron therapy device designed solely for transdermal electron delivery and is not a medical device.

The electron generator was reclassified as a non-medical device by omitting the insulated mat accessory and removing the negative potential therapy function from the “(1) Reducing Electron Therapy Device classified as a medical device for healthcare professionals.”

Based on the following reasoning, Reltech launched its electronic power supply as a reduction therapy device that is more affordable and easier to use for a wider range of people.

1. The essential function of “(1) reduction electron therapy devices classified as medical devices for healthcareprofessionals” is the transdermal electron delivery function, not the negative potential therapy function.The negative potential therapy function applies a high negative voltage to the human body while it is isolated from the ground; it is not a function that supplies electrons to the human body via microcurrents. Therefore , no antioxidant effect can be expected from the negative potential therapy function.
2. The transcutaneouselectron deliveryfunction and the negative potential therapy function do not significantly affect each other. Therefore, even if the negative potential therapy function is removed from “(1) a reduced-electron therapy device classified as a medical device for healthcare professionals, ” it is unlikely that the remaining transcutaneous electron delivery function would be affected.
3. The insulated mat, which is an accessory to the “reduced-electron therapy device classified as a medical device for healthcare professionals (1), ” does not allow moisture to pass through. Therefore, it cannot be used comfortably in high-humidity environments or when the user is sweating heavily.

Similarities and Differences Between Two Types of Reduced-Electron Therapy Devices

The differences between “(1) a reduced-electron therapy device classified as a medical device for healthcareprofessionals” and “(2) a reduced-electron therapy device classified as an electron supply device” are as follows.

Common Elements—Body Structure, Parts, etc.

Structure and Components of the Main Unit Related to the Parts That Interact with the Human Body

The structure and components of the main units of all Lertech medical devices and power supplies that come into contact with the human body are identical.

Manufacturing and Quality Control

All of Reltech’s medical devices and power supplies are manufactured and quality-controlled at the company’s own factory in Japan, in accordance with the Ministerial Ordinance on Medical Device Quality Management Systems and the manufacturing processes for medical devices prescribed by law. Reltech has also obtained ISO 13485 certification.

Differences—Suggested Retail Price, etc.

Setting the suggested retail price for electronic power supplies on the lower side

As described in the “Comparison ofReduced-ElectronTherapyDeviceModels ” section below, in order to make reduced-electron therapydevices accessible to as many people as possible, we have set the suggested retail price for the electron generators at a low level. In particular, we have positioned the HsD — which is compact, lightweight, highly portable, and easy to use —as our flagship model for widespread adoption, and have set its price significantly lower than that of other models.

The electronic power supply is a non-medical device that does not have a negative potential therapy function.

As mentioned above, (1) the electron reduction therapy device, which is classified as a medical device for healthcare professionals, is categorized as such due to its negative potential therapy function. On the other hand, the electron supply unit does not come with an insulated mat for negative potential therapy. Therefore, the electron supply unit is not a medical device equipped with a negative potential therapy function.

Electronic feeders have no therapeutic benefits or effects.

Since electron generators are not medical devices, they do not have any indicated uses or effects. On the other hand, (1) reduction electron therapy devices, which are classified as medical devices intended for healthcare professionals, are indicated for “relief of headaches, stiff shoulders, insomnia, and chronic constipation.”

When using an electronic dispenser, a doctor's prescription is not required.

(1) If you purchase or rent a reduction electron therapy device classified as a medical device for healthcare professionals, you must present a written document, such as a medical certificate, indicating a doctor’s instructions. On the other hand, (2) for electron supply devices, a doctor’s instructions are not required.

The electron gun's function has been partially detuned.

As described in the “Comparison of Reduced-Electron Therapy Device Models ” section below, (1) the functions of reduced-electron therapy devices —which are classified as medical devices for healthcare professionals—have been partially detuned (reduced in performance), resulting in electron supply devices.This is because electron supply devices are used in a wider variety of environments than medical devices, which are subject to stricter usage and storage regulations; the company sought to enhance fault tolerance through this detuning. Reltech considers this detuning to be within a range that does not substantially impair the transdermal electron supply function, which is the essential function of the electron reduction therapy device.

Comparison of Reduced-Electron Therapy Devices

Models with 2-channel output

Trade Name	Reltech MD21	HD21 Electron Supply Unit
Exterior
Device Classification: (Designation under the Pharmaceutical and Medical Devices Act)	Medical Devices for Healthcare Professionals (Electrotherapy Device (Class II))	Non-medical device (None)
Indications and Effects	Relief from headaches, insomnia, stiff shoulders , and chronic constipation	None
Features	; Negative Potential Therapy Function	Transdermal Power Delivery Function
Number of Simultaneous Output Channels	2	2
Output Voltage	DC – 5.5 ± 0.5 kV	DC – 5.0 ± 1.0 kV
Output Plate AC	Select either S or H	S only
Treatment Time Settings	Up to 99 minutes	Up to 60 minutes
Suggested Retail Price	1,210,000 yen (tax included)	990,000 yen (tax included)
	Go to the "Medical Devices for Healthcare Professionals" page	Go to the "Electron Supply Unit" page

Popular Models

Trade Name	[Discontinued] MSD reltec	(HsD) (Released September 2, 2024)
Exterior
Device Classification: (Designation under the Pharmaceutical and Medical Devices Act)	Medical Devices for Healthcare Professionals (Electrotherapy Device (Class II))	Non-medical device (None)
Indications and Effects	Relief from headaches, insomnia, stiff shoulders , and chronic constipation	None
Features and More	Transcutaneous electrical stimulation function Negative potential therapy function Current monitoring function Operates with a power switch only; no start button	Transcutaneous electrical stimulation function Output monitoring function Equipped with a power switch and operation button
Number of Simultaneous Output Channels	1	1
Output Voltage	DC – 5.0 ± 1.0 kV	DC – 4.5 ± 0.9 kV
Output Plate AC	H only	H only
Treatment Time Settings	Up to 120 minutes	Up to 60 minutes
Suggested Retail Price	605,000 yen (tax included)	330,000 yen (tax included)
	Go to the "Medical Devices for Healthcare Professionals" page	Go to the "Electron Supply Unit" page

Standard Model

Trade Name	[Discontinued] Reltech MD11	HD11 Electron Supply Unit
Exterior
Device Classification: (Designation under the Pharmaceutical and Medical Devices Act)	Medical Devices for Healthcare Professionals (Electrotherapy Device (Class II))	Non-medical device (None)
Indications and Effects	Relief from headaches, insomnia, stiff shoulders , and chronic constipation	None
Features	; Negative Potential Therapy Function	Transdermal Power Delivery Function
Number of Simultaneous Output Channels	1	1
Output Voltage	DC – 5.5 ± 0.5 kV	DC – 5.0 ± 1.0 kV
Output Plate AC	Select either S or H	S only
Treatment Time Settings	Up to 99 minutes	Up to 60 minutes
Suggested Retail Price	660,000 yen (tax included)	550,000 yen (tax included)
		Go to the "Electron Supply Unit" page

Which electron-reduction therapy device should you choose?

Reltech developed its various models of reduced-electron therapy devices based on the following principles. Please use this information as a reference when selecting a model. There are three key points to consider when selecting a model:

• Is the intended use “treatment of illness” or “maintenance/promotion of health”?
  Reltech believes that for the “treatment of illness,” reduction electron therapy devices —which are classified as medical devices intended for healthcare professionals —should be used under a physician’s supervision.
• Can you ensure that you have a place where you can use the device for a certain minimum amount of time while lying on your back?
  Reltech believes that the effectiveness of reduced-electron therapy devices depends on the duration and frequency of use, and that using the device while lying on your back yields better results.
• When introducing a reduced-electron therapy device at a facility, we believe it is appropriate to select a two-channel output model, which offers high theoretical performance in terms of transcutaneous electron delivery.

(1) Those who use it to treat an illness

(2) People who use it to maintain or improve their health

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(3) Equipment Selection for Corporations and Facilities

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