International Clearances
Avazzia’s Bio-Electric Stimulation Technology™ (B.E.S.T.™) devices are cleared, licensed or approved in countries
across the globe. Avazzia’s quality manufacturing system is ISO 13485:2016 and MDSAP certified to meet current
accepted standards.

U.S. Clearance
The company’s devices are U.S. FDA cleared for chronic, intractable, post-surgical and post-traumatic pain relief with a
prescription. Avazzia’s over-the-counter, without a prescription, devices are FDA cleared for aches and pains from daily
activities or exercise.

Health Canada
Health Canada: (license 82321 (2017-10-24) devices for combination TENS and EMS kits, includes Tennant
Biomodulator).
TENS for pain relief and relief from chronic pain, acute pain, intractable pain, post-surgical pain, and posttraumatic
pain.
Electric Muscle Stimulation for: Increase range of motion; relaxation of muscle spasm; prevention or retardation
of disuse atrophy; increasing local blood circulation; muscle re-education, immediate post-surgical.

Europe CE Certification
Europe CE Certification: (240130-2017-CE-NOR-NA-PS Rev. 1.0, includes Tennant Biomodulator) TENS for
pain relief and relief from chronic pain, acute pain, intractable pain, post-surgical pain, post-traumatic pain with
prescription.
Electric Muscle Stimulation for: increase range of motion, relaxation of muscle spasm, prevention or retardation
of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical. CES for
depression, anxiety, and sleep disorders. Supra-orbital for migraines. Aesthetic uses, cosmetic appearance.

Singapore HSA
Singapore HSA: (DE0503495 Device Registration, MB4-13-180905-01 CSDT Sing r0.06)
Indications for use for TENS medical uses in this CSDT include pain relief, EMS, CES, and accelerated wound
healing marketed to the public without prescription required as is the case in reference jurisdictions including
the EU, Canada, and Malaysia.
Over-the-counter, without prescription indications for uses: TENS for pain relief: chronic pain, acute pain,
intractable pain, post-surgical pain, post-traumatic pain, back pain, shoulder pain, neck ache, Carpal Tunnel
Syndrome, Plantar Fasciitis, Tennis Elbow, nerve problems, Arthritis, neuropathic nerve pain and cosmetic
appearance.
TENS for EMS: improved results when used with massage therapy, muscles strain, increase range of motion,
circulation issues, release of chronic trigger points, relaxation of muscle spasm, prevention or retardation of
disuse atrophy, Increasing local blood circulation, muscle re-education, immediate post-surgical, wound
healing, rapid healing after surgery, bone fracture, bruising, Scoliosis, neuropathy, frozen shoulder and sports
injury.
TENS-OTC: Avazzia BEST electrical stimulation devices: Pain from sore and aching muscles in the shoulder,
waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal
household work activities
CES: anxiety, sleep disorders, relaxation, and sense of wellbeing.
Supra orbital: migraines.
With Prescription only indications for use: CES for depression, Insomnia, Post traumatic stress disorder

Malaysia
Malaysia: (GB64850143017 – Medical Device Registration Certificate – 20220206, MB4-13-151106-01 Rev 02
CSD Malaysia r0.10)
7.2.2 Intended use
TENS: Transcutaneous Electrical Nerve Stimulation (TENS) for symptomatic relief and management of chronic
intractable pain, post-traumatic and post-surgical pain
EMS: Electro-Muscle Stimulator (EMS) for relaxation of muscle spasm, prevention or retardation of disuse
atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis and maintaining or increasing range of motion
7.2.3 Indications: TENS, chronic pain, acute pain, Intractable pain, post surgical pain, post-traumatic pain
EMS: relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood
circulation, and muscle re-education, immediate post-surgical.