Internationally Well Recognized Product
Internationally Approved CERAGEM Master V3/V4
These accreditations safeguard the interests of users and prospective buyers by ensuring that the CERAGEM MASTER V3/V4 Therapeutic Thermal Massager meets or exceeds requirements established by experts in the field.
As for the efficacy and effect of the product, CERAGEM Master V3/V4 is approved by the United States, Europe, China, and Russia as well as Korea. (KOREA Ministry of Food and Drugs Safety, US FDA, EUROPEAN CE, China FDA, Russia FDA-Roszdravnadzor).
CERAGEM secures professionalism in the spine and scientific research through the obtainment of certificates from nationally certified agencies all over the world such as the U.S. Food and Drug Administration (FDA), MDD of the European Union, Korean Food and Drugs Administration.
The CERAGEM Master V3/V4 was certified by the KOREA Ministry of Food and Drugs Safety, US FDA, EUROPEAN CE and etc., for the relief of muscle pain, relaxation of muscles, and enhancement of blood circulation at the application site.
UL KOREA Certificated
In 2009, CERAGEM R&D Center was recognized as a UL WTDP (Witness Test Data Program) & CB-TMP (Testing on Manufacturers Premises) laboratory by UL Korea (Underwriters Laboratories Inc.) as the first domestic warmth device manufacturer. Therefore, CERAGEM R&D Center has a qualification to obtain UL certificate and CB/CE certificate using Test Data executed by researchers of the R&D Center using its own facilities and test equipment for medical devices (UL/IEC/EN60601-1) developed and produced by CERAGEM in the presence of a UL Engineer.
Ceragem R&D Center passed the strict screening of UL Korea on each item such as facility, manpower, and manual in obtaining the qualification. Passing UL Korea’s evaluation means that UL Korea officially certified the facilities and the testing equipment of Ceragem R&D Center and the researcher at the same level as the UL Lab. This outcome is the result of Ceragem has continuous investment and interest in the R&D field.
US Food and Drug Administration has cleared CERAGEM V3/V4 for :
1. Temporary muscle relaxation
2. Temporary increases in local circulation where applied
3. Temporary relief of minor muscle and joint pain and stiffness
4. Temporary relief of minor joint pain associated with arthritis.
When the U.S. Food and Drug Administration (FDA) clears a medical device like CERAGEM V3/V4 for specific uses, it means that the device has been evaluated and deemed safe and effective for those particular purposes.
Let's break down each of the points:
1. Cleared for temporary muscle relaxation:
This indicates that CERAGEM V3/V4 is safe and effective in helping to relax muscles temporarily. This could be beneficial for individuals experiencing muscle tension or stiffness due to various reasons such as stress, physical activity, or underlying medical conditions.
2. Cleared for temporary increases in local circulation where applied:
CERAGEM V3/V4 has been found to promote temporary increases in blood circulation in the areas where it is applied. Improved circulation can have various benefits, including better delivery of oxygen and nutrients to tissues, removal of waste products, and potentially aiding in the healing process.
3. Cleared for temporary relief of minor muscle and joint pain and stiffness:
CERAGEM V3/V4 can provide temporary relief from minor muscle and joint pain and stiffness. This could be particularly helpful for individuals dealing with discomfort from everyday activities, minor injuries, or conditions like muscle strains or sprains.
4. Cleared for temporary relief of minor joint pain associated with arthritis:
Arthritis is a common condition characterized by joint inflammation and pain. CERAGEM V3/V4 has been shown to offer temporary relief from the minor joint pain associated with arthritis, which can improve the quality of life for individuals dealing with this chronic condition.
EU MDD Requirements
The EU MDD stipulates that: Medical devices must not compromise the clinical condition or safety of patients. Medical devices must not present any risk to the persons implanting them, nor to others. Devices must perform as intended by the manufacturer.
CE is not a quality mark, but compliance with the EU Medical Devices Regulation requires to meet specific standards of performance, quality, safety, and efficacy of a product.
European Medical Device CE Approval for CERAGEM V3/V4:
1. Approved to aid in muscle relaxation therapy
2. Temporary relief minor muscle and joint pain stiffness
3. Temporary increase in local circulation where applied.
Chinese Pharmacopoeia
In CHINA, through a clinical trial, the CERAGEM Master V3 was approved by Chinese Pharmacopoeia, CFDA (China Food and Drug Administration) as an adjuvant action for alleviating 12 symptoms, including:
1. Hypertension
2. Type 2 diabetes
3. Chronic fatigue
4. Chronic gastritis
5. Prostatitis
6. Insomnia
7. Constipation
8. Cervical vertebrae disorder
9. Lumbar disc herniation
10. Psoas muscle injury
11. Pelvic inflammation
12. Spondylolisthesis
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
IN RUSSIA, CERAGEM Massage Bed has been allowed by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) in the territory of the Russian Federation to be used as a medical product.
According to studies done by the Central Clinical Hospital of the Russian Academy of Sciences, CERAGEM can be used both in medical practice and at home without the accompaniment of medical personnel.
CERAGEM Massage Bed has been successfully used for many years to treat and prevent various diseases in the physiotherapy rooms of medical institutions in the Russian Federation.
In 2005, when the CERAGEM company first entered the Russian market, numerous tests were required to obtain the status of a medical device. The device has been successfully tested on the basis of all departments of medical institutions.
Positive reactions were observed in more than 80% of cases and NO COMPLICATIONS were recorded! After 15 years, Russian doctors continue to investigate the effect of the CERAGEM Thermal Massagers. In the year 2020, they published the test results of bronchopulmonary diseases.
Today, CERAGEM Massage Bed is used in more than 20 leading hospitals and clinics in RUSSIA, such as the General Military Hospital. Academician N. N. Burdenko, ICS-SK them. Bakuleva, GU GII Influenza RAMS.
This website uses cookies to improve user experience.
By clicking agree you consent to all cookies in accordance with our Privacy Policy.