(189 days)
The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.
The Prizm Medical, Inc. Micro-Z™ Stimulation System is also used for Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. These uses were previously cleared under K951727.
Prizm Medical, Inc. Micro-Z™ Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the Micro-ZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro® strip that attaches the device to the Velcro® arm/leg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons.
The provided text is a 510(k) summary for the Prizm Medical, Inc. Micro-Z™ Stimulation System, which is a Transcutaneous Electronic Nerve Stimulator (TENS) device. This document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory submission for substantial equivalence to a predicate device, not a performance study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification, indications for use, device description, and claiming substantial equivalence to a legally marketed device (Empi Focus). It does not present data from performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).