(184 days)
The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes.
The AMPCARE ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
AMPCARE ES cutaneous electrodes are indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes.
The provided text is related to an FDA 510(k) clearance for the AMPCARE ESP™ Therapy System, a powered muscle stimulator. However, it does not contain information about acceptance criteria or specific study data proving the device meets those criteria.
The document states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was cleared based on its similarity to existing devices, and typically, a 510(k) submission doesn't require new clinical efficacy studies if substantial equivalence can be established through technological characteristics and performance data demonstrating it's as safe and effective as a predicate device.
To answer your specific questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed engineering report for the device. The current document is primarily an FDA clearance letter.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 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).