(543 days)
The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes, which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patient get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for this type of device) | Reported Device Performance from Clinical Study (for dysmenorrhea) |
|---|---|
| Safe for its intended use | No technical problems detected; Usability received good scores. (Implied safety from lack of adverse events reported in summary) |
| Effective for symptomatic relief and management of chronic pain (general) | The study specifically focused on dysmenorrhea. Performance for general chronic pain is not detailed in this summary for the "new" indication. |
| Effective for temporary relief of pain associated with sore and aching muscles (e.g., shoulder, waist, back, etc.) | The study specifically focused on dysmenorrhea. Performance for muscular pain is not detailed in this summary for the "new" indication. |
| Effective for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with OTC pain medication | Reduction in Visual Analogue Scale (VAS) score: |
- Livia: Average 28.1 points reduction
- Sham: Average 17.6 points reduction
- Statistically significant difference (P
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).