Home Care Self-Adhesive Electrodes
by Home Care Technology Co., Ltd.
510(k) K022917
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022917 | Date4 Mar 2003 | 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- Withdrawn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
- Full name
- Home Care Various Models of Self-Adhesive Electrodes
- 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
This device is a self-adhesive electrode (Product Code GXY) designed for recording physiological signals, such as electroencephalograms, or delivering electrical stimulation. It falls under the FDA’s classification for neurological monitoring and therapeutic applications, adhering to the nomenclature for reusable or single-use adhesive electrodes.
The electrodes are supplied sterile or non-sterile depending on the model and intended use, with variations in size and adhesive properties for patient compatibility. They are regulated under FDA 510(k) clearance (K022917) and must be used in accordance with clinical guidelines for skin preparation and application. No MRI safety classification or reusable sterilisation instructions are specified in the regulatory data.
Other devices from Home Care Technology Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Are these electrodes intended for reusable use, or are they meant to be single-use only? How does that affect their sterility?
These electrodes are designed for both reusable and single-use applications, depending on the specific model. Sterility varies by model—some are supplied sterile while others are non-sterile. The reusable models require proper cleaning and sterilization procedures (though none are specified in the regulatory data), while single-use models are intended for one-time application only. Always check the packaging or documentation for the specific model’s sterility status and usage instructions.
What types of physiological signals can these electrodes record, and what are they commonly used for in clinical settings?
These self-adhesive electrodes are primarily designed for recording physiological signals such as electroencephalograms (EEGs), which monitor brain activity, as well as delivering electrical stimulation for therapeutic purposes. They are classified under neurological monitoring and therapeutic applications, making them suitable for use in EEG studies, neuromuscular testing, or other electrophysiological assessments where precise signal capture or stimulation is required.
How do I determine which size or model of these electrodes is best suited for my patient’s needs?
The electrodes come in various sizes and adhesive properties tailored for patient compatibility. The specific model should be selected based on the patient’s skin type, the area of application, and the intended use (e.g., recording or stimulation). For example, some models may have a stronger adhesive for sensitive skin or larger surface areas. Always refer to the product documentation or consult with the manufacturer to ensure the correct size and adhesive type align with your clinical requirements.
Can these electrodes be used in an MRI environment, or are there any safety concerns I should be aware of?
The regulatory data for these electrodes does not specify any MRI safety classification or instructions for use in an MRI environment. This means there is no explicit confirmation that they are safe for MRI use, nor is there guidance on whether they contain metallic components or other materials that could pose risks in a magnetic field. If MRI compatibility is required, additional verification or alternative devices should be considered.
How should these electrodes be stored, and are there any special handling instructions I need to follow?
Storage instructions are not explicitly detailed in the provided regulatory data, but standard practices for self-adhesive electrodes should be followed. Generally, they should be stored in a cool, dry place away from direct sunlight and extreme temperatures. If the electrodes are sterile, they should remain in their sealed packaging until ready for use. Always check the packaging or manufacturer’s guidelines for any model-specific storage recommendations to maintain efficacy and sterility.