What makes Synapse unique?
In simple terms it is the level or strength of the current used that differentiates one electrical treatment device from another. Synapse micro-current operates at similar levels to the body's natural electrical systems. In general terms micro-current uses a very low level of current, operating at cellular level. This is in contrast to devices using stronger intensity that can cause muscle contractions as a cause of mechanical effect
Synapse Microcurrent Ltd
is a leading medical technology based company specializing in developing and taking to market scientifically proven, clinically relevant medical devices.
Synapse was incorporated in January 2003 and in the early years focussed its efforts in defining IP rights, refining and securing patents and with subsequent product development.
This work led in 2007, to Synapse achieving ISO 9001 Quality Management Systems & ISO 13485 accreditation for the design and manufacture of their micro-current devices for medical and sports applications.
In addition, Synapse has several patents already granted and several pending in key territories of the world as well as a number of registered trademarks.
Synapse’s medical devices have been designed to be prescribed by clinicians for specific medical conditions and self administered by the patient and as such are single program, treatment specific devices.
Synapse's wound Management: Accel Heal® device - facilitates an accelerated rate of healing in all wounds especially poorly healing, non-healing chronic and difficult to heal wounds.
In 2009 independently conducted clinical trials on Chronic "non-healing" venous leg ulcers was completed. This study demonstrated that the Synapse Accel-Heal® device made significant reductions in wound size, exudate levels and pain in a significant proportion of the trial patients.
Accel-Heal® carries the CE mark having been tested and approved by Notified Body 0120. It is certified as a Class IIA device and has full Medical Device Directive approval under MDD 93/42/EEC establishing safety and approval to be sold in European markets. Accel-Heal® is manufactured to ISO 13485:2003 for the design and manufacture of medical devices and our Quality Management System holds ISO 9001:2008 accreditation.
Click here to download a (pdf) copy of the ISO 13485 certification
Click here to download a (pdf) copy of the ISO 9001 certification
Click here to download a (pdf) copy of the ISO 93/42 EEC certification
click to download a (pdf) copy of the declaration of conformity
Currently, Synapse is currently going through the process of gaining FDA and TGA certification which will enable Synapse to sell Accel-Heal® in the USA and Australia respectively.
