The Cefaly STX-Med TENS device, intended for the prophylactic treatment of migraines, is presented in this user manual. TENS devices, including the Cefaly STX-Med, are designed to alleviate pain through electrical stimulation applied to the skin’s surface. TENS therapy has effectively addressed chronic pain, post-operative discomfort, and pain from injuries when other treatments fail.
Distinguishing itself by regulatory classification, the Cefaly STX-Med was sanctioned by the FDA via a de novo 510(k) in 2014 for migraine prevention in adults. Subsequently, the Cefaly Acute and Cefaly Dual received clearance for both acute migraine management and prophylaxis. Other brands like Allive and HeadaTerm have also been approved for similar indications.
As medical devices governed by the FDA, TENS units such as the Cefaly STX-Med, dating back to initial market entries post-May 1976, have been subjected to the 510(k) clearance process. This process equates contemporary devices to their predicate counterparts without necessitating clinical efficacy data. However, the devices obtained prescription-based or non-prescription pathways could differ in stimulation intensity.
What TENS Offers and Its Principles of Operation
Operated typically with battery power, TENS devices operate by generating electrical pulses transmitted through electrodes to the skin at the pain site. Its potential therapeutic effects may stem from endorphin release and interruption of local pain signaling pathways. Additionally, TENS has been postulated to aid in neurological conditions like dementia by modifying neurotransmitter levels and enhancing brain activity.
Alternatives to traditional TENS include percutaneous electrical nerve stimulation (PENS) using subdermal microneedles and interferential stimulation, which provides deep tissue penetration and may improve circulation to the targeted area.
Usage, Contraindications, and Regulatory Aspects
Usage of these devices extends across various environments, from homes to outpatient clinics. In 2018, the Cala ONETM TENS device by Cala Health was approved as a temporary treatment for hand tremors in patients with essential tremor; however, it should not be used by patients with certain electrical medical implants or seizure disorders.
The manual likely outlines operational guidance, precautions, contraindications, and care instructions for the Cefaly STX-Med TENS device. Users should consult the complete manual and a healthcare professional to ensure proper use and to clarify prescription requirements and any device-specific operation procedures.
Manual:
Download: Cefaly STX-Med Transcutaneous Electrical Nerve Stimulator (TENS) User Manual
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