Guidelines for TGA compliant advertising claims for RITMSCENAR devices and treatments
RITMSCENAR Devices are Class IIa medical devices and in Australia their import, distribution and advertising are strictly regulated by the Therapeutic Goods Administration (TGA).
RITM Australia is the legal sponsor of RITM OKB product range.
SCENAR Home, SCENAR Sport, SCENAR Sport D, SCENAR Pro and SCENAR Pro Plus are listed under one number in ARTGA 140659 with the following intended use:
“The device is intended to be used as an analgesic peripheral nerve stimulator, to be placed on the skin and is used to treat pain associated with surgery, trauma, musculoskeletal problems, bursitis or dental problems. It may also be used in physical therapy and during labour/delivery”
The bioSCENAR is listed in ARTGA under No: 209483 with the following intended use:
“BioSCENAR Professional is a non-invasive, electrotherapeutic, hand-held device and is intended to be used as an analgesic peripheral nerve stimulator, to be placed on the skin to treat pain associated to surgery, trauma, musculoskeletal problems, bursitis and dental problems; to facilitate functional restoration and improvement; it may also be used in physical therapy and during labour/delivery.”
The above therapeutic claims about RITMSCENAR devices are verified and proven by clinical researches that have been accepted by TGA as sufficient clinical evidence. Therapeutic claims outside the intended purpose of the devices are illegal.
SCENAR Practitioners and distributors who advertise devices and treatments directed to consumers must comply with the Therapeutic Goods Advertising Code (ATGAC).
All marketing and advertising materials including web sites that promote SCENAR therapy and devices have to only include claims within the scope of the intended purpose of each listing.
Advertising of SCENAR therapy and devices also have to contain correct and balanced statements and MUST NOT:
(a) be likely to arouse unwarranted and unrealistic expectations of product effectiveness;
(b) be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases;
(c) mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions;
(d) abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress;
(e) contain any matter which is likely to lead persons to believe:
(i) that they are suffering from a serious ailment; or
(ii) that harmful consequences may result from the therapeutic good not being used.
(f) encourage, or be likely to encourage, inappropriate or excessive use;
(g) contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain, guaranteed or sure cure;
(h) contain any claim, statement or implication that it is effective in all cases of a condition;
(i) contain any claim, statement or implication that the goods are safe or that their use cannot cause harm or that they have no side-effects; or
SCENAR devices and treatments CANNOT be advertised for treatment, cure or prevention of serious diseases:
• Diseases of joint or rheumatic disease,
• Mental disturbances,
• Diseases of pancreas
• Diabetes
• Nervous system diseases
• Cardiovascular diseases
Claims such as : * safe * cannot cause harm * have no side effects * claims for treatment, cure or prevention of mental illness (including depression)
are prohibited.
Examples of advertising intended purpose of SCENAR devices in Australia
RITM Australia
SCENAR is an electro-bio-controlled device ideal for pain management in various functional and pathological processes. It is used to alleviate pain and facilitate functional restoration and improvement.
SCENAR does not treat a particular disease or condition, it stimulates the body’s own healing recourses.
SCENAR therapy can be used as a complementary or mono therapy to treat pain associated:
• Surgery
• Trauma
• Musculoskeletal problems
• Bursitis
• Dental problems
It may also be used in physical therapy and during labour/delivery NS Health
What is SCENAR® ?
SCENAR® is an advanced form of electrotherapy and may be effective in treating acute and chronic pain. SCENAR® therapy functions on two physiological principles: that the body has its own healing capabilities and that it is continually employing processes of self-regulation to maintain health.
The SCENAR® device is a small, hand-held device with transdermal electroneuro-stimulator, graphic display (Professional models), light emitting diodes (models for home use) and audible indications. It delivers non-invasive, computer-modulated therapeutic electro- stimulation via a patient’s skin and involves high amplitude, short-duration waveforms with little discomfort to patients.
Due to this device’s high amplitude, small unmyelinated ‘C’ fibres can be stimulated to a higher degree than with other forms of electrotherapy. When sufficiently stimulated ‘C’ fibres trigger neuro- and regulative-peptide release with resultant pain relief and healing.
The SCENAR® impulse is carried via afferent nerve fibres to regulatory centres in the brain which in turn responds via efferent nerve fibres. SCENAR® interprets this response and, via computer modulation, results in its next impulse being modified accordingly which further provides information back to the brain to either amplify or dampen the pathological signals initiating pain, ultimately leading to homeostasis. SCENAR® therapy protocols include rating of pain, measurement of range of movement and testing of movement related to functional impairment.
The SCENAR® device is small, portable, user-friendly, and is relatively low-cost. Patients may benefit from faster recovery times, versatility and few concurrent medication interactions.
The SCENAR® device establishes a biofeedback link with the body when in use, constantly changing the properties of the applied electric impulses, depending on the measured reaction from the body.
The effect of SCENAR® is based on electric impulses of a specific shape; patterned after the natural nervous discharges of the human body.
The SCENAR® device not only provides direct therapeutic effect, but also activates the natural defences of the body.₁ ₂ The effect is achieved through the stimulation of reflective zones and acupuncture points on the skin surface.
Overall, SCENAR® is an effective, non-invasive medical technology, which works by stimulating the body’s inherent self-healing mechanisms with minimal undesirable side effects.