(105 days)
Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for an Electronic Muscle Stimulator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details you've requested.
The document confirms that the device (Electronic Muscle Stimulator, Model: MP01) is substantially equivalent to legally marketed predicate devices for specific indications for use:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, toning, and firming of arms and legs.
It also notes that the device is intended for Over-The-Counter Use.
To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance against specific acceptance criteria.
§ 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).