Electro-stimulation devices (ESDs) were developed in Russia in the mid-seventies by A. Karasev, based at Sochi University, and extensively refined by Professor A.N. Revenko (neurologist) and Ya.Z. Grinberg (electrical engineer) and many physicians and scientists based in Taganrog.¹ They were first to achieve repeatable therapeutic results using electrical signals to stimulate the immune system.

ESDs were created for use by the Russian military and space programs with the advantages of being inexpensive, lightweight, space saving, and a practical substitute for pharmaceutical therapy. Pharmacy supplies on board space vessels were reduced, saving space and weight. In 1986 the first electro-stimulation device passed technical and clinical trials and was given permission by the USSR Medical Council to be used in hospitals and in homes. ESDs are carried by the Russian Military and are used to treat shock and as a substitute for morphine on the battlefield. It is known that Russian ESDs were probably developed at a much earlier date than officially stated. Before their release to the world, they remained closely guarded state secrets. After the formal dissolution of the USSR, ESD technology was declassified and released to the world for humanitarian relief as a gesture of good will and a furtherance of Perestroika.

The original ESD high failure rate (40% within first year) was due to overly complex circuitry, inferior components, and other reliability and signal quality issues. Avazzia Inc. of Dallas, Texas, has further redefined the ESD concept. Avazzia Inc. produced the BEST concept and based its BEST family of devices upon a superior and redefined concept: simplification by redefining ESD waveforms to create unique, focused areas of neurological signaling.

A primary mission for Avazzia Inc. was to design and develop BEST devices for effective muscular rehabilitation and retraining, as an aid for pain relief, alleviation of edema via increased perfusion, lymphatic drainage, and a variety of other inflammatory and degenerative conditions. Some BEST models are classified by FDA as Exempt Class II Biofeedback devices and require a prescription from a health practitioner.†

BEST therapy utilizes redefined ESD concepts as a complementary method of promoting the body’s own healing processes through neurological signalling by electronic biofeedback and increasing the electron/ATP content (cellular redox potential) of tissue.

† Biofeedback-controlled electro-stimulators are regulated by the United States Food and Drug Administration under the provision of the U.S. Code of Federal Regulations, Vol. 21, Section 882.5050, Generic Name: Biofeedback Device, Product Code: HCC, Class II. The FDA has exempted certain Class II devices from the 510(k) pre-market notification requirement in a Notice published in the Federal Register, January 21, 1998, p. 84, including battery-powered biofeedback devices for prescription use in relaxation training and muscle re-education.

CFR 21 Sec. 882.5050 Biofeedback device (a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.)so that the patient can control voluntarily these physiological parameters. (b) Classification. Class II (special controls). The device is exempt from pre-market notification procedures in subpart E of part 807 of this chapter when it is a prescription battery-powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.