Identifiers
- 510(k) Number
- K183154 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)
SM Electrodes are cutaneous electrodes classified under product code GXY as Electrode, Cutaneous. They are designed for use in neurological applications as indicated by the advisory committee classification.
The device was cleared through the FDA 510(k) process under K183154 on March 26, 2019, following a traditional review. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited in Shenzhen, China, and is classified as a Class II device subject to special controls.
Frequently asked questions
What are SM Electrodes used for?
SM Electrodes are cutaneous electrodes designed for use in neurological applications, as indicated by their advisory committee classification under product code GXY for Electrode, Cutaneous devices.
How were SM Electrodes authorized for market release?
SM Electrodes were cleared through the FDA 510(k) process under submission K183154 on March 26, 2019, following a traditional review and determined to be substantially equivalent to a predicate device.
Who manufactures SM Electrodes and where are they produced?
SM Electrodes are manufactured by Hong Qiangxing (Shenzhen) Electronics Limited at their facility located in Shenzhen, China, specifically at 4f, Jingcheng Bldg., Xicheng Industrial Zone, Xixiang Rd., Bao'An District.
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: K183154 FDA 510 (k) - SM Electrodes, Sm Electrodes 510 (k) FDA Premarket Notification K183154 Hong Qiangxing ..., K183154 - Electrode, Cutaneous FDA 510 (k) APPLICATION FOR Hong ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183154 | Class II | Active |
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Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (1)
- FDA 510(k) K183154 24 fields · synced Oct 6, 2026