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North Coast Buffered Iontophoresis Electrode

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052019

by North Coast Medical, Inc.

Identifiers

510(k) Number
K052019 FDA 510(k)
FDA Product Code
EGJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5525 FDA 510(k)
Regulation Number
890.5525 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The North Coast Buffered Iontophoresis Electrode is a reusable medical device designed for iontophoresis, a non-invasive technique that uses a mild electric current to deliver soluble salts, drugs, or other substances transdermally into the body. Classified as a Physical Medicine device, it facilitates therapeutic ion delivery for conditions managed in physical medicine settings, such as localized edema, hyperhidrosis, or drug administration alternatives to injections.

Supplied as a reusable electrode, the device is intended for clinical use in controlled environments such as physical therapy or outpatient clinics. It operates with a carbon-Ag/AgCl electrode technology and delivers current up to 80 mA-min for precise iontophoresis. Sterilization instructions are not specified in the data, but its reusable nature requires adherence to standard medical device reprocessing protocols. The device holds FDA 510(k) clearance (K052019) under the Physical Medicine advisory committee, classified as a Class II medical device under regulation 21 CFR 890.5525.

Frequently asked questions

What types of medical conditions is the North Coast Buffered Iontophoresis Electrode primarily used to treat in clinical settings?

The device is designed for iontophoresis, a non-invasive technique used to deliver substances transdermally for conditions managed in physical medicine, such as localized edema or hyperhidrosis. It also serves as an alternative to injections for drug administration in controlled clinical environments like physical therapy or outpatient clinics.

How is the North Coast Buffered Iontophoresis Electrode supplied and what does its reusable nature imply for clinical use?

The electrode is supplied as a reusable medical device, meaning it must be properly cleaned, disinfected, and maintained between uses according to standard medical device reprocessing protocols. Its reusable design allows for repeated use in clinical settings, but proper sterilization or disinfection procedures must be followed to ensure patient safety and device functionality.

What is the maximum current capacity of the North Coast Buffered Iontophoresis Electrode, and how does this relate to its clinical application?

The device delivers a maximum current of up to 80 mA-min, which enables precise iontophoresis for therapeutic purposes. This capacity ensures controlled and effective transdermal delivery of substances, making it suitable for treating conditions like localized edema or hyperhidrosis in physical medicine settings.

Is there any specific regulatory pathway or advisory committee involved in the approval of this device, and what does that mean for its use?

The device holds FDA 510(k) clearance (K052019) under the Physical Medicine advisory committee, classified as a Class II medical device under regulation 21 CFR 890.5525. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended clinical applications.

What types of environments or facilities are best suited for using the North Coast Buffered Iontophoresis Electrode?

The device is intended for clinical use in controlled environments such as physical therapy clinics or outpatient settings where iontophoresis can be safely and effectively administered. These settings ensure proper monitoring and adherence to medical protocols, which are essential for the device’s therapeutic applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Norco Buffered Iontophoretic Delivery Kit - North Coast Medical, Iontophoresis - North Coast Medical, North Coast Buffered Iontophoresis Electrode, Norco™ Buffered Iontophoresis Delivery Kit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
North Coast Medical, Inc.

Sources (1)

  • FDA 510(k) K052019 24 fields · synced Sep 19, 2026