Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)— 510(k) K253237
Substantially EquivalentElde Medikal Sanayi ve Ticaret Anonim Sirketi
FDA 510(k) clearance K253237 for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode), Substantially Equivalent on 2026-05-08. Applicant: Elde Medikal Sanayi ve Ticaret Anonim Sirketi. Device class: 2.
Summary
Elde Medikal's Elde Medical Electrodes are listed in two sizes, T5 (5 cm x 5 cm) and T10 (5 cm x 10 cm). The product code is GXY, cutaneous electrodes.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Elde filed from Umraniye/Istanbul, Turkey. The decision came 221 calendar days after receipt (September 29, 2025 to May 8, 2026).
Clearance details
- Applicant
- Elde Medikal Sanayi ve Ticaret Anonim Sirketi
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Umraniye/Istanbul, TR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.