Lectec Stimulating Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872250 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Lectec Corp. →

• What types of pain conditions can the Lectec Stimulating Electrode help manage, and how does it work?

  The Lectec Stimulating Electrode is designed for transcutaneous electrical nerve stimulation (TENS), which delivers electrical impulses to peripheral nerves to temporarily relieve pain signals. It is intended for managing acute or chronic pain conditions by modulating how pain signals are perceived by the body. The device is not a cure but provides temporary relief through external application to the skin.

• Is the Lectec Stimulating Electrode reusable, or is it meant for single-use only?

  The Lectec Stimulating Electrode is explicitly supplied as a single-use, non-sterile device. This means it is intended for one-time application per patient and should not be reused, even after cleaning or reprocessing, to ensure safety and effectiveness.

• How should I store the Lectec Stimulating Electrode before use, and does it require special handling?

  Storage follows standard medical device protocols to maintain functionality. Since it is non-sterile and single-use, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or integrity before use, and handle it with care to avoid contamination or damage.

• What regulatory pathway was followed for FDA clearance of the Lectec Stimulating Electrode?

  The Lectec Stimulating Electrode received FDA clearance through a 510(k) submission (K872250) under the Traditional review pathway. It was deemed Substantially Equivalent (SESE) to a predicate device and falls under product code GXY, with the Neurology advisory committee (NE) overseeing the review. This classification confirms it as a Class II medical device.