(251 days)
For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS): Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS): Symptomatic relief or management of chronic, intractable pain, Post-traumatic acute pain, Post-surgical acute pain. For FES: Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait. For DC Continuous Mode: Relaxation of muscle spasm. For EMG: To determination the activation timing of muscles for: a) retraining of muscle activation, b) coordination of muscle activation, An indication of the force produced by muscle for control and maintenance of muscle contractions, Relaxation muscle training, Muscle re-education. For EMG triggered Stim: Stroke rehab by muscle re-education, Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. For Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Relief of pain, muscle spasms and joint contractures, 2. Relief of pain, muscle spasms and joint contractures that may be associated with: a) Adhesive capsulitis, b) Bursitis with slight calcification, c) Myositis, d) Soft tissue injuries, e) Shortened tendons due to past injuries and scar tissues, 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: a) Capsular tightness, b) Capsular scarring.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria. The document is a 510(k) substantial equivalence letter from the FDA for a device called "Vectra GENiSYS (Intelect Legend XT)".
This document primarily:
- Identifies the trade name, regulation numbers, regulation names, regulatory class, and product codes for the device.
- States that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
- Outlines general controls and additional controls that may apply to the device.
- Lists the specific "Indications for Use" for various modalities offered by the device (e.g., VMS, Interferential, Microcurrent, TENS, FES, DC Continuous Mode, EMG, EMG triggered Stim, Ultrasound).
The text does not contain details on:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Any study design (e.g., sample size, data provenance, ground truth establishment).
- Any performance results or data to demonstrate the device meets acceptance criteria.
- Information about expert involvement, adjudication methods, or MRMC studies.
Therefore, I cannot provide a response filling in the requested table and details because the information is not present in the provided document.
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.