Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
by Elde Medikal Sanayi Ve Ticaret Anonim Sirketi
510(k) K253237
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253237 | Date8 May 2026 | 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- Withdrawn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, 1 Oct 2026
The Elde Medical Electrodes are reusable adhesive electrodes designed for surface electromyography (sEMG) and electrotherapy applications. These electrodes facilitate the transmission of electrical signals between a stimulator or monitor and the patient’s skin, enabling diagnostic or therapeutic interventions in neuromuscular assessments. The T5 model measures 5 cm × 5 cm, while the T10 model measures 5 cm × 10 cm, accommodating varying anatomical sites and clinical needs. Constructed for durability, they incorporate conductive gel interfaces to ensure consistent signal conduction and patient comfort during prolonged use.
Supplied sterile or non-sterile as specified by the manufacturer, these electrodes are intended for single-patient or multi-patient use depending on reprocessing protocols. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance (K253237) following a review by the Neurology Advisory Committee. Storage requires protection from moisture, extreme temperatures, and direct sunlight to preserve functionality. The electrodes are compatible with standard electromyography and electrotherapy systems, adhering to MRI-safe guidelines for non-metallic components.
Other devices from Elde Medikal Sanayi Ve Ticaret Anonim Sirketi
Questions
AI-generated answers, 1 Oct 2026
What are the Elde Medical T5/T10 electrodes used for?
The Elde Medical T5/T10 electrodes are designed for surface electromyography (sEMG) and electrotherapy applications. They facilitate the transmission of electrical signals between a stimulator or monitor and the patient’s skin, enabling diagnostic assessments in neuromuscular evaluations or therapeutic interventions. The T5 model (5 cm × 5 cm) and T10 model (5 cm × 10 cm) accommodate different anatomical sites and clinical needs.
Are these electrodes reusable or single-use?
The Elde Medical Electrodes are reusable, built for durability with conductive gel interfaces to ensure consistent signal conduction and patient comfort during prolonged use. They can be used for single-patient or multi-patient applications, provided they are properly reprocessed between uses.
What storage conditions are required for these electrodes?
To maintain functionality, store the Elde Medical Electrodes in a dry environment, protected from moisture, extreme temperatures, and direct sunlight. Proper storage ensures the adhesive and conductive gel remain effective for repeated use.
Are these electrodes compatible with MRI systems?
Yes, the Elde Medical Electrodes are designed with non-metallic components, adhering to MRI-safe guidelines. This makes them suitable for use in MRI-compatible electromyography and electrotherapy systems when appropriate clinical protocols are followed.
How do I determine if these electrodes are sterile or non-sterile?
The sterility of the Elde Medical Electrodes depends on the specific order or packaging as specified by the manufacturer. They can be supplied sterile or non-sterile, so verify the packaging instructions or consult the manufacturer’s documentation to confirm the intended use case.