(30 days)
Apex Medical Digital EMS is intended to be used in:
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- Relaxation of Muscle Spasm.
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- Prevention or retardation of disuse atrophy.
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- Increase local blood circulation.
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- Muscle re-education.
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- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
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- Maintaining or increasing range of motion.
Not Found
The provided text describes a 510(k) premarket notification for the Apex Medical Digital EMS, models TS1311 and TS1312, and the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report.
The letter from the FDA is an approval letter based on the review of the 510(k) submission. It states that the device is substantially equivalent to a legally marketed predicate device. This implies that the device would have met specific criteria and undergone testing to demonstrate that substantial equivalence, but the details of those tests are not in this particular document.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based solely on the provided text. The document confirms the regulatory classification and the intended uses, but not the technical study details.
§ 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).