Identifiers
- 510(k) Number
- K141076 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)
Garment electrodes are cutaneous electrodes intended to be used with legally marketed electrical stimulating devices. They are designed to deliver electrical stimulation through garment-integrated electrode placement.
The device is supplied non-sterile and is intended for single use. It has received FDA 510(k) clearance under K141076, with a decision of substantially equivalent, and is classified under product code GXY.
Frequently asked questions
What are garment electrodes intended for?
Garment electrodes are cutaneous electrodes intended to deliver electrical stimulation through garment-integrated electrode placement when used with legally marketed electrical stimulating devices.
Are garment electrodes sterile or non-sterile, and are they for single use or reuse?
The device is supplied non-sterile and is intended for single use only, as stated in the specifications and description, to ensure safe and effective cutaneous electrical stimulation without reprocessing.
What regulatory clearance do garment electrodes have and under what product code?
Garment electrodes have received FDA 510(k) clearance under K141076 with a decision of substantially equivalent and are classified under product code GXY for cutaneous electrode devices.
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: GARMENT ELECTRODES 510 (k) K141076 - FDA.report, Garment Electrodes - Beudamed, Shenzhen Dongdixin Technology Co., Ltd. - fda.report, Shenzhen Dongdixin Technology Co.… · DeviceClearance, FDA Browser - Cleared 510 (K) - GARMENT ELECTRODES (K141076)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141076 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (1)
- FDA 510(k) K141076 24 fields · synced Sep 26, 2026