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KM-10 TENS Electrode

by Katecho LLC 510(k)

Active United States

510(k) K000870

Overview

The KM-10 TENS Electrode is a cutaneous electrode designed for transcutaneous electrical nerve stimulation (TENS). It delivers low-voltage electrical pulses to the skin for pain management, typically used in neurology applications to modulate pain signals along peripheral nerves.

This single-use electrode is supplied sterile and falls under FDA 510(k) clearance (K000870) as a Class II device under regulation 882.1320. It is intended for one-time application and must be stored according to manufacturer instructions to maintain sterility. The device adheres to traditional clearance standards and is classified under product code GXY.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000870 Date7 Nov 2000ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GXY
FDA applicant
Katecho, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the KM-10 TENS Electrode primarily used for in clinical settings?

    The KM-10 TENS Electrode is designed for transcutaneous electrical nerve stimulation (TENS), a technique used in pain management. It delivers low-voltage electrical pulses to the skin to help modulate pain signals along peripheral nerves, particularly in neurology applications where pain relief is the goal.

  • Is the KM-10 TENS Electrode intended for single-use or repeated applications, and how should it be handled to maintain safety?

    The KM-10 TENS Electrode is explicitly designed for single-use only. Since it is supplied sterile, it must be used once and then discarded. Proper storage according to the manufacturer’s instructions is critical to preserve sterility before use, ensuring safety and effectiveness.

  • What storage conditions are required to keep the KM-10 TENS Electrode sterile and functional?

    The KM-10 TENS Electrode must be stored following the manufacturer’s guidelines to maintain sterility. While specific conditions aren’t detailed here, typical sterile single-use electrodes require protection from moisture, extreme temperatures, and physical damage. Always refer to the included packaging instructions for precise storage recommendations.

  • How does the KM-10 TENS Electrode’s regulatory classification affect its use in clinical environments?

    The KM-10 TENS Electrode is classified as a Class II device under FDA regulation 882.1320 and holds a 510(k) clearance (K000870). This means it has undergone FDA review for safety and effectiveness, ensuring it meets established standards for transcutaneous nerve stimulation devices. Clinicians can rely on its compliance with these regulations when incorporating it into pain management protocols.