HOME CARE JELLY

• K Number: K022494
• Device Name: HOME CARE JELLY
• Manufacturer: ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
• Date Cleared: 2002-12-02 ( 126 days)
• Product Code: GYB
• Regulation Number: 882.1275
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Home Care Jelly," an electroconductive media. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

This document is a regulatory clearance letter and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth. The letter's purpose is to grant market clearance based on substantial equivalence, not to present a detailed performance study.

Regulation Number and Section

§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).