Licenses & Certifications
In 2022, RITM OKB ZAO passed a number of planned certification audits. As the result, international certificates of quality and safety of medical devices were received.
The Special Design Bureau “RITM” has become one of the few companies in the world that has passed a high-level verification for compliance with the EU Medical Device Regulation MDR 2017/745 requirements. The new Regulations turned to be much more demanding than the previous MDD ones. The auditors paid special attention to the risk analysis, clinical evaluation and safety of medical devices. As a result of a successful assessment, the CE mark (the EU quality management system certificate) was obtained, which signifies that our products meet high safety, health, and environmental protection requirements of the EU, and can be marketed there.
In December 2022, RITM OKB ZAO received the renewed ISO 9001 and 13485 certificates (international quality management standards, where the 1st applies to organizations across industries, and the 2nd – to the medical device industry). GCERTI Co. Ltd., the accredited international certification body recognized the company’s quality management system as complying with the international standards.
Also, last year RITM OKB ZAO confirmed the quality of SCENAR devices according to the requirements of the US, Mexico, South Korea, and received the relevant certificates and permits. The auditors assessed total product life cycle including development and modernization, manufacturing processes, sanitary control, maintenance, storage, and user interaction and training procedures.
Despite the complicated international political and economic situation, RITM OKB ZAO products are in high demand, and we continue to successfully export them to the world market. Our devices are registered and represented in 36 countries including but not limited to: the US (FDA), Israel, Mexico, Australia, Russia, etc..
The first SCENAR device prototype was manufactured in 1976
- 1986 – First SCENAR Patent
- 1990 – First Certification of SCENAR devices in the agencies of the Ministry of Health
- 2006 – ISO 9001, ISO 13485
- 2006 – CE Mark -2265– European Directive 93/42/EEC
- 2006 – Korea FDA-134153,134151
- 2009 – Australia ARTG 140659,164651
- 2010 – FDA 510(K) USA K092117, K131513
- 2012 – Health Canada MDL:86149,MDL# 89860
- 2013 – Mexico COFEPRIS Sanitary Certificate
- 2019 – Ministry or Health Israel
Names you repeatedly come across are A.N.Revenko, Y.Grinberg, and Y.Gorfinkel as well as Karasev.
In 1973, Dr. Alexander Karasev, created the first Russian TENS device which was designed to block pain.
Following this development in 1973-1975, Karasev released the first device designed to be able assist the body’s healing properties, not just block pain signals.
SCENAR development had begun.
In the late 1980’s Karasev received his first patent US0005257623 for an electro-stimulator. Imbedded within this filing were many SCENAR attributes.
The SCENAR® is the registered trademark which belongs to RITMSCENAR OKB, Inc in the US. SCENAR® devices and their accessories (SCENAR) are Transcutaneous Electrical Nerve Stimulators (TENS) machines.
RITMSCENAR OKB Inc. sells SCENAR® under the following brand names which are all trademarked (registration number and jurisdiction):
SCENAR ® (RU TM – 187500, EM TM – 001249218, US TM – 86693081, MX TM – 0119851824766, SG TM – T1107178B, NZ TM – 782867, PH TM – 42008000394, WO TM – 941064); GENUINE SCENAR ® (US TM – 86030768)
The patent application No. 15778519 “METHOD OF ADAPTIVE ELECTRIC ACTION ON A LIVING ORGANISM (VARIANTS)”
(authors Y.Z. Grinberg, Y.Y. Starovoytov, M.A. Unakafov) has received a positive decision!
That ensures the protection of the Russian patent No.2645923 from December 1st, 2015, in the United States.
The idea of this patents is the bioadaptive treatment modes of SCENAR and CHANS devices.
This unique technology provides for the most effective interaction between the device and the body and helps to obtain quick positive results via
the automatic adjustment of the treatment parameters depending on the body reactions.
Bioadaptive modes is a significantly new level of adjustment of the SCENAR signal depending on the body response.
The operating modes with biocontrolled feedback are now patented in the United States!
