Certifications

 

Certifications

  • ISO-13485 Quality Certified - Medical Products
  • CE Approved in Europe - Microcurrent, Biofeedback Device
  • CB Safety Certified - Meet Safety Standards IEC 60601-1, 60601-1-2 TENS


Government Clearance

  • FDA cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain (available by prescription only).

  • HealthCanada cleared as a microcurrent, biofeedback device for muscle training and re-education, electrical nerve stimulation, improved circulation, improved range of motion; and, management of chronic pain, intractable pain, post-surgical pain and traumatic pain


FDA Compliance

Tennant Biomodulator Slimline Plus® device and accessories are US FDA cleared as Biofeedback micro-current TENS devices indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post- traumatic pain. US Federal law restricts these devices to sale by or on the order of a physician.

  • 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 re-education and prescription use, subject to 882.9.

 

 

 



 
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