FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text describes a 510(k) premarket notification for MSB Tens Electrodes and the FDA's determination of substantial equivalence. However, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document is a regulatory letter from the FDA to MSB Limited, confirming that their Tens Electrodes are substantially equivalent to devices marketed prior to May 28, 1976. This letter signifies a regulatory clearance to market the device, but it does not detail the testing or studies that led to this determination. Such studies would typically be part of the 510(k) submission, but their results are not included in this particular document.

Therefore, I cannot provide the requested information based on the given text.

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K Number

K944497

Device Name

UNILECT, MONITAB AND BIOTRACE-HR

Manufacturer

MSB LTD.

Date Cleared

1996-05-17

(612 days)