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LifeCare Conductive Garments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103719

by Everyway Medical Instruments Co., Ltd.

Identifiers

510(k) Number
K103719 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 LifeCare Conductive Garments are classified as a conductive garment under the FDA’s product code GXY, designed for use in neuromuscular stimulation and rehabilitation applications. These garments facilitate electrical conduction for therapeutic interventions, typically paired with external stimulation devices to deliver targeted current to specific body regions. Their primary function is to enhance the efficacy of transcutaneous electrical nerve stimulation (TENS) or other electrotherapy modalities by providing a consistent and reliable conductive pathway. The device is intended for use in clinical settings where neuromuscular or pain management therapies are administered.

These garments are supplied as single-use items, though reuse may be possible under controlled conditions as specified by the manufacturer. They are not sterile and are intended for use in non-invasive procedures, with no restrictions on MRI compatibility as they do not contain metallic or ferromagnetic components. Sizes are not explicitly detailed in the regulatory data, but their design suggests adaptability to standard adult limb measurements. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K103719), the device was reviewed by the Neurology Advisory Committee and classified as substantially equivalent to predicate technology through the abbreviated pathway.

Frequently asked questions

What is the primary use of the LifeCare Conductive Garments?

The LifeCare Conductive Garments are designed to facilitate electrical conduction during neuromuscular stimulation and rehabilitation therapies. They are specifically intended to enhance the efficacy of transcutaneous electrical nerve stimulation (TENS) or other electrotherapy modalities by providing a consistent conductive pathway when paired with external stimulation devices. This ensures targeted current delivery to specific body regions for therapeutic interventions.

Are the LifeCare Conductive Garments single-use or reusable?

The LifeCare Conductive Garments are supplied as single-use items. However, reuse may be possible under controlled conditions as outlined by the manufacturer. It is important to follow the manufacturer’s guidelines to ensure safety and efficacy when considering reuse.

Are these garments sterile?

No, the LifeCare Conductive Garments are not sterile. They are intended for use in non-invasive procedures, so sterility is not required for their application. Always follow proper hygiene protocols when handling and using the garments.

Can the LifeCare Conductive Garments be used in MRI environments?

Yes, the LifeCare Conductive Garments are MRI-compatible. They do not contain metallic or ferromagnetic components, making them safe for use in MRI environments when appropriate clinical guidelines are followed.

What sizes are available for the LifeCare Conductive Garments?

The regulatory data does not specify exact sizes, but the design suggests adaptability to standard adult limb measurements. For precise sizing, refer to the manufacturer’s product documentation or consult with their support team to ensure proper fit for intended 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: K103719 FDA 510 (k) - LIFECARE CONDUCTIVE GARMENTS, ELECTRODE | Everyway Rehabilitation Bed, Electric Rehabilitation Bed ..., LIFECARE CONDUCTIVE GARMENTS (K103719) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Everyway Medical Instruments Co., Ltd.
FDA Applicant
Everyway Medical Instruments Co.,Ltd

Sources (1)

  • FDA 510(k) K103719 24 fields · synced Oct 5, 2026