(189 days)
The X2ABS Dual Channel Fitness Belt is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes:
- Improvement of muscle tone of the muscles in the abdomen.
The X2ABS Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
X2ABS Dual Channel Fitness Belt is a two channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrodes for signal connection to skin. The built-in electrodes are located on the inner surface of the belts.
Power is derived from 2 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a powered muscle stimulator, and it primarily focuses on demonstrating substantial equivalence to a predicate device.
The "Performance Summary" section (Chapter 6, Section 7) mentions that "Testing has been carried out to assure compliance with recognized electrical safety standards" and that "Performance data has been verified according to the requirements of the FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices." It also states, "The waveform test report has also been provided to verify the parameters of the device." However, it does not provide specific details about:
- Acceptance Criteria: What quantitative or qualitative metrics were established for device performance.
- Reported Device Performance: The actual results obtained from these tests against any specific criteria.
- Study Design: No description of a clinical or non-clinical study that would typically gather performance data against such criteria.
- Sample sizes, data provenance, ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The document concludes that the device is "substantially equivalent" to the predicate device, implying that its performance is considered acceptable because it's similar to an already cleared device, not necessarily because it has met new, distinct performance criteria through a specific study outlined here.
§ 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).