Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

• K Number: K190118
• Device Name: Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
• Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.
• Date Cleared: 2020-05-13 ( 475 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA to Guangzhou Xinbo Electronic Co., Ltd. regarding the 510(k) premarket notification for their Dr-Ho's Foot Pad Electrode. This document primarily focuses on regulatory approval, classification, and general controls.

The letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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).