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Electro-Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K932299

by Prizm Medical, Inc.

Identifiers

510(k) Number
K932299 FDA 510(k)
FDA Product Code
GXY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Electro-Mesh is a garment electrode designed for electrotherapy applications. It delivers low-level direct current (DC) micro-amperage through flexible, textile-based conductive material, enabling precise and comfortable stimulation for clinical use. This device is classified under the product code GXY (Neurology) and is intended for non-invasive electrical stimulation therapies. Its mesh construction allows for conformable placement on the skin, facilitating patient comfort and adherence during treatment.

Electro-Mesh is supplied as a single-use device, intended for sterile application in clinical settings such as outpatient clinics, rehabilitation centers, or home healthcare environments. The mesh panels are pre-sterilized and packaged for immediate use, ensuring compatibility with standard electrotherapy equipment. No specific MRI safety information is provided, but its use should adhere to standard electrotherapy protocols to avoid interference with other medical devices. The device holds FDA 510(k) clearance under the Neurology (NE) Advisory Committee, with a clearance date of July 1, 1994.

Frequently asked questions

What types of electrotherapy treatments is the Electro-Mesh designed to support, and how does its mesh design improve patient comfort during use?

The Electro-Mesh is designed for non-invasive electrical stimulation therapies, particularly those classified under neurology applications (product code GXY). Its flexible, textile-based conductive mesh allows for conformable placement on the skin, reducing irritation and improving adherence compared to rigid electrodes. This design ensures a secure fit during treatments like transcutaneous electrical nerve stimulation (TENS) or other low-level DC micro-amperage therapies, enhancing patient comfort and compliance.

Is the Electro-Mesh intended for reuse, or is it meant to be used only once? How does this affect its clinical use?

The Electro-Mesh is explicitly supplied as a single-use device, pre-sterilized and packaged for immediate clinical application. This design ensures hygiene and safety in settings like outpatient clinics, rehabilitation centers, or home healthcare, where sterility is critical. Single-use also eliminates the need for cleaning or reprocessing, streamlining workflow and reducing infection risks.

What storage conditions should be followed for the Electro-Mesh to maintain its sterility and functionality?

Since the Electro-Mesh is pre-sterilized and packaged for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The sealed packaging preserves sterility, so avoid exposing it to moisture, contaminants, or physical damage. Check the packaging for expiration or sterility indicators before use.

How does the Electro-Mesh integrate with standard electrotherapy equipment, and are there any special considerations for its use?

The Electro-Mesh is designed to be compatible with standard electrotherapy devices that deliver low-level direct current (DC) micro-amperage. Its textile-based conductive material ensures reliable electrical contact without requiring additional gels or adhesives. While no specific MRI safety information is provided, its use should follow general electrotherapy protocols to avoid interference with other medical devices in the vicinity, such as pacemakers or monitoring equipment.

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: Prizm Medical Inc., Electrotherapy | Prizm Medical Inc., PRIZM MEDICAL, INC. EMSP44 Electro-Mesh Panel - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Prizm Medical, Inc.

Sources (1)

  • FDA 510(k) K932299 24 fields · synced Sep 20, 2026