(184 days)
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
The provided document is a 510(k) summary for the HIVOX Spopad EMS SP-910, SP-920, and SP-620, which are powered muscle stimulators. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the way a clinical trial might.
Therefore, the information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (as typically found in AI/ML device evaluations) is not present in this 510(k) summary. These devices are much simpler than AI-powered diagnostic tools and rely on established electrical safety and performance standards for their regulatory clearance.
However, I can extract the relevant comparison information that serves as the basis for the declaration of substantial equivalence, which implicitly acts as the "criteria" for approval in this context.
Here's a summary based on the provided text, aligning with your request where possible, and noting when information is unavailable:
Acceptance Criteria and Device Performance (Implicit from Predicate Comparison)
For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The following table summarizes the comparison made by the manufacturer. The reported device performance is presented in comparison to the predicate, with the conclusion that differences are minor and do not raise new safety or effectiveness concerns.
| Feature/Parameter | Acceptance Criteria (Predicate Device K092476, Model 4M) | Reported Performance (HIVOX Spopad EMS SP-910, SP-920, SP-620) |
|---|---|---|
| Intended Use | Improvement of muscle tone/firmness, strengthening muscles in arms, abdomen, thighs, buttocks; Not for therapy or treatment of medical conditions. | Improvement of muscle tone/firmness, strengthening muscles in arms, abdomen, thighs, buttocks; Not for therapy or treatment of medical conditions. (Same) |
| Technology | Electrical Muscle Stimulation | Electrical Muscle Stimulation (Same) |
| Power Source | 1.5V battery * 3 | 3V Battery * 1 |
| Method of Line Current Isolation | Battery supply | Battery Supply (Same) |
| Patient Leakage Current (Normal Condition) |
§ 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).