(230 days)
The Livia is designed for symptomatic relief and management of chronic intractable 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. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
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 patiernt 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.
The provided text is a 510(k) summary for the device "Livia." It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states in Section 9: "Discussion of Clinical Tests Performed: Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices."
This directly indicates that no clinical study was performed or required for the Livia device to obtain 510(k) clearance based on substantial equivalence to existing predicate devices. Therefore, I cannot provide details on acceptance criteria or a study that proves the device meets those criteria, as such a study was not conducted or submitted for this specific 510(k) clearance.
The document primarily focuses on demonstrating that the Livia device has similar technological characteristics and performs comparably to the predicate devices (Philips Consumer Lifestyle PulseRelief (K151035) and NeuroMetrix ASCEND (K10433)), and that non-clinical testing was deemed sufficient by the manufacturer and accepted by the FDA for this substantial equivalence determination.
§ 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).