HFX Trial Stimulator (EXTS3500) - Analgesic spinal cord electrical stimulation system pulse generator

Intended purpose

The HFX iQ System and HFX Trial System are devices intended to provide stimulation therapy to the spinal cord through implanted leads. They are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. The HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy. The HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).

Functional description

The HFX Trial Stimulator is a battery-powered, single-use, externally worn device used to evaluate the effectiveness of the stimulation therapy prior to receiving an Implantable Pulse Generator (IPG) for ongoing therapy. The HFX Trial Stimulator has connections for up to two leads with eight electrodes each and can be programmed to stimulate the nerves in the spinal cord through the electrodes on these leads.