MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

• K Number: K990370
• Device Name: MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
• Manufacturer: MSB,UK
• Date Cleared: 1999-04-12 ( 63 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Stimus latio OV INTERFERENTIAL

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for MSB (Electrical Stimulation) Electrodes from 1999. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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

The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data or clinical study results that would typically include acceptance criteria and performance metrics.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).