Mailuokang Self-Adhesive Electrode
by Shenzhen Mailuokang Technology Co., Ltd.
510(k) K152815
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152815 | Date8 Mar 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Mailuokang Self-Adhesive Electrode is a reusable, conductive adhesive interface designed to facilitate electrical stimulation by connecting patient skin to stimulation devices. It serves as a critical component in neurostimulation therapies, ensuring reliable signal transmission while maintaining patient comfort and skin integrity.
This device is supplied as a reusable medical product, intended for use in clinical settings where electrical stimulation is applied. It adheres directly to the skin without requiring additional preparation, though proper cleaning and storage per manufacturer guidelines are essential. The electrode is classified under FDA product code GXY and received 510(k) clearance (K152815) as substantially equivalent to a predicate device, adhering to regulatory standards for Class II medical devices.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical settings or procedures is this reusable electrode primarily used for?
The Mailuokang Self-Adhesive Electrode is designed for use in clinical settings where neurostimulation therapies are applied, such as physical therapy, pain management, or neuromuscular electrical stimulation. Its conductive adhesive interface ensures reliable signal transmission between the patient’s skin and stimulation devices, making it suitable for procedures requiring consistent electrical stimulation while prioritizing patient comfort and skin integrity.
How should the electrode be cleaned and stored to maintain its reusability and performance?
Since this electrode is reusable, proper cleaning and storage are critical to preserve its adhesive properties and conductive performance. The manufacturer’s guidelines must be followed for cleaning—typically involving gentle disinfection and thorough drying—to prevent contamination or degradation. Storage should be in a clean, dry environment, away from direct sunlight or extreme temperatures, to ensure longevity and reliability for repeated use.
What distinguishes this electrode’s design from other reusable electrodes in terms of patient comfort and application?
The Mailuokang Self-Adhesive Electrode is specifically designed to adhere directly to the skin without requiring additional preparation like shaving or abrasion, which can reduce patient discomfort. Its conductive adhesive interface is formulated to maintain a secure connection while minimizing irritation or skin damage, making it ideal for prolonged or repeated use in neurostimulation therapies where comfort and reliability are essential.
Are there different sizes or models available for this electrode, and how would a clinician determine the appropriate fit for a patient?
The provided specifications do not detail specific sizes or models for the Mailuokang Self-Adhesive Electrode, so additional information would need to be obtained directly from the manufacturer. Typically, clinicians would select an electrode based on the patient’s anatomical area (e.g., limb, torso) and the stimulation device’s requirements, ensuring proper coverage and conductivity. If multiple sizes exist, the manufacturer’s sizing guide or compatibility documentation would guide the choice.