(244 days)
The Electromagnetic Stimulation System is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
The HS-591 Electromagnetic Stimulation System is a non-invasive therapeutic device which comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue of adult patients. The device is equipped with a color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided text is a 510(k) summary for an Electromagnetic Stimulation System. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that "Clinical Testing" is "not applicable" and relies on performance testing and validation studies to demonstrate substantial equivalence to the predicate device.
Therefore, the document does not contain any information regarding specific acceptance criteria for device performance related to a clinical study, nor does it provide details of a study that proves the device meets such criteria. It is a regulatory submission focused on demonstrating equivalence for marketing clearance, not a report on a clinical trial with performance metrics.
For that reason, I cannot provide the requested information, as it is not present in the provided text.
If you are looking for information about clinical acceptance criteria and performance studies for a medical device, you would typically need to consult clinical trial reports, peer-reviewed publications, or more detailed regulatory submissions (like a PMA, if applicable, which this device is not).
§ 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).