(57 days)
Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:
- Relaxing muscle spasms
- Increasing local blood circulation.
- -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Muscle re-education.
- Maintaining or increasing range of motion
- Preventing or retarding disuse atrophy
EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. Both EMS 5.0 and EMS 5.1 are analogue units with dual channel. EMS 5.0 has a selectable pulse rate of 5, 30 and 100 Hz, while EMS 5.1 has an adjustable pulse rate of 2 to 150 Hz.
The provided text from K072795 is a 510(k) summary for an Electrical Muscle Stimulator (EMS) device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on the regulatory aspects of demonstrating substantial equivalence, which often relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies for this type of device.
Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The submission explicitly states: "This series is safe and effective as the predicate devices cited above." This implies that the safety and effectiveness are established by reference to the predicate devices, not through a separate study detailed in this document.
§ 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).