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Wrap Accessory Electrodes (GMX-ABSBELT01 +8 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240108

by Gymmax Technology (Shenzhen) Co., Ltd.

Identifiers

510(k) Number
K240108 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
Wrap Accessory Electrodes (GMX-ABSBELT01 FDA 510(k)
GMX-ABSBELT02 FDA 510(k)
GMX-WRIST01 FDA 510(k)
GMX-ELBOW01 FDA 510(k)
GMX-LEG01, GMX-ANKLE01, GMX-KNEE01 FDA 510(k)
GMX-FOOT PAD01 FDA 510(k)
GMX-GLOVES01 FDA 510(k)
SHOULDER01 FDA 510(k)
GMX-NCK01) 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)

Wrap Accessory Electrodes are medical devices designed for use with electrotherapy equipment. These electrodes come in various sizes and shapes to accommodate different body parts including wrists, elbows, legs, ankles, knees, feet, shoulders, and neck.

The electrodes are supplied as single-use or reusable devices depending on the specific model. They are intended for use in clinical settings and have received FDA 510(k) clearance with product code GXY. The devices are manufactured by Gymmax Technology (Shenzhen) Co., Ltd. and are designed for neurology applications.

Frequently asked questions

What are Wrap Accessory Electrodes used for?

Wrap Accessory Electrodes are designed for use with electrotherapy equipment in clinical settings. They come in various sizes and shapes to accommodate different body parts including wrists, elbows, legs, ankles, knees, feet, shoulders, and neck, intended for neurology applications.

Are these electrodes single-use or reusable?

The electrodes are supplied as either single-use or reusable devices depending on the specific model. The manufacturer offers multiple models with different usage specifications to meet various clinical needs.

What regulatory approvals do these electrodes have?

Wrap Accessory Electrodes have received FDA 510(k) clearance with product code GXY. They were cleared through the traditional pathway with a decision code of SESE (Substantially Equivalent) on June 10, 2024.

What models of Wrap Accessory Electrodes are available?

The electrodes are available in multiple models including GMX-ABSBELT01, GMX-ABSBELT02, GMX-WRIST01, GMX-ELBOW01, GMX-LEG01, GMX-ANKLE01, GMX-KNEE01, GMX-FOOT PAD01, GMX-GLOVES01, SHOULDER01, and GMX-NCK01, each designed for specific body parts.

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: Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01 ..., 510(k) Premarket Notification - Food and Drug Administration, Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gymmax Technology (Shenzhen) Co., Ltd.
FDA Applicant
Gymmax Technology Shenzhen Co., Ltd.

Sources (1)

  • FDA 510(k) K240108 24 fields · synced Sep 28, 2026