Avazzia BEST™ devices are Microcurrent, Biofeedback, Electro-Stimulation Devices cleared by the FDA for use transcutaneously for relief of pain. The products are hand-held, battery-powered devices that apply relaxation-stimulation pulses and are effective, portable, and economic solutions to address the healthcare concerns of today’s active population.
Founded in 2004 to design, manufacture, and distribute innovative healthcare products and software.
They are based in Dallas, TX. and have devised devices for specific treatments and problems, and they are the pioneers of BEST™ technology. Founded in 2004 to design, manufacture, and distribute innovative healthcare products and software.
Biofeedback Electro-Stimulation Technology (BEST™) is briefly reviewed and an explanation of therapeutic applications and neurophysiology based upon electron loading, i.e., increased cellular capacitance, and stimulation of nonmyelinated C and myelinated A nerve fibers to secrete neuropeptides leading to a cascade of multiple other neuro-active substances such as neurotransmitters, histamine and 5-HT (serotonin) is presented.
In addition, neuropeptide synthesis is up-regulated leading to a quantitative increase in endogenous neuropeptide production by C fibers. BEST™ impulses induce neuropeptides secretion by primarily C nerve fibers, and have profound and wide-ranging effects, triggering complex regulative chains and cascades.
Multiple biochemical pathways utilizing many types of neuro-mediators, hormones, and cytokines are involved. Although peptide half-life in body fluids is relatively short, other mediators in the cascades survive for many hours. Some regulatory peptides act on genomic activity to alter gene expression and change biochemical synthesis.
BEST™ electrical signals can reprogram tissues locked into chronic vegetative and dysfunctional states by inducing bolus synthesis of regulatory peptides (RP).
BEST™ impulses also are relayed through afferent© neural pathways to the CNS and give rise to various 1) segmental spinal reflexes by efferent signals sent from the cord to organs associated with that segment or back to the local tissue receiving the impulse; 2) systemic reactions such as endorphin induction by efferent§ signals descending from the cortical and subcortical areas of the brain i.e. pain reduction.
BEST™ impulses have a direct effect on blood perfusion. Clinically observable and welldefined increases in tissue perfusion at the treated areas are due to neuropeptide-induced vasodilatation, particularly Substance P. A combination of BEST™-induced axon reflexes also releases other vaso-active substances such as kinins, prostaglandins, cytokines, and nitric oxide. The end result is that blood flow to a treated area is significantly increased. Other neuropeptides and endocrine secretions released by BEST™ impulses mediate inflammation. Complement fixation and tissue injuries due to immune aggression are suppressed, and cellular immunity is enhanced by macrophage proliferation, activation, chemotaxis, and clearance of extracelluar debris.
BEST, based upon older electro-stimulation concepts, has redefined existing technology with novel waveforms, improved circuitry, and cleaner signaling. Signaling is focused and intensified for narrow applications or is expanded with unique signaling combinations and frequency ranges for increased therapeutic flexibility. The Avazzia unit is the first generation of BEST. Compared with the earlier Russian electro-stimulation devices, Avazzia generates cleaner and more precisely defined wave forms and possesses both newer (patent pending) settings that expand clinical versatility and vastly improved operational reliability.
Our Safety Acknowledgements.
Avazzia devices have the following Clearances for use in the treatment of Pain Management
- FDA clearance: Avazzia BEST-RSI™ Best-Pro 1™, and Body-Stim™ Devices and accessories are FDA cleared for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.
- Health Canada Clearance: Avazzia License Number 82319 assign to Avazzia Company ID: 131173. – AVAZZIA BLUE™, BEST-PRO™, BEST-RSI™, BODY-STIM™, MED-BEST™, MED-SPORT™, PRO-SPORT BIOFEEDBACK™ and the following wires and attachments:- Lead Wire 130, Lead wire 250 and Splitter Lead Wire, Ankle electrodes, arm/leg wrap, back wrap, cervical wrap, comb electrode, conductive carpal tunnel electrode, conductive clip electrodes, conductive sock/glove, elbow/knee/leg/shoulder wraps, y electrode, self adhesive pads, pencil electrode, finger electrode. These devices have all been approved by Health Canada under License Number shown above.
- CE mark: Avazzia BEST™ Devices and accessories have been certified and approved for CE mark use as TENS devices.
- CB Safety Certificate: Avazzia BEST™ Devices and accessories have been certified to meet safety standards IEC 60601-1, 60601-1-2 for TENS devices.
- ISO13485: Avazzia has recieved the prestigious ISO13485 Quality Certification for medical products.
You can see license details on this PDF document Avazzia Certificates