TENS/FES/NMES Electrodes

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

510(k) Number

K962332 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Easy Flex Tens/Fes/Mns Electrodes 2 Round Model 8200/2X2 Model 8220

  Class II

  FDA 510(k) K961141 Active Cleared 10 May 1996

• Tantone Multi-Day #633 Tens Electrode

  Class II

  FDA 510(k) K871222 Active Cleared 29 May 1987

• Tens/Fes/Nmes Electrodes

  Class II

  FDA 510(k) K983097 Active Cleared 17 Sep 1999

• Conduct Aloe Gel, #UP239-8FL. Oz/#UP245 G-1 Gallon

  Class II

  FDA 510(k) K925466 Active Cleared 26 Aug 1993

• Spec T.E.N.S. Prewired Repositionable Tens Electrode - Modify

  Class II

  FDA 510(k) K962910 Active Cleared 5 Sep 1996

• What are TENS/FES/NMES Electrodes used for?

  These electrodes are designed to deliver electrical stimulation to nerves and muscles for therapeutic purposes when used with transcutaneous electrical nerve stimulation (TENS), functional electrical stimulation (FES), and neuromuscular electrical stimulation (NMES) devices.

• Are these electrodes single-use or reusable?

  The electrodes can be either single-use or reusable depending on the specific product design. The manufacturer offers various configurations to meet different clinical needs and application requirements.

• What sizes and models of electrodes are available?

  The electrodes are available in various sizes as specified by the manufacturer. Different sizes may be optimized for different applications, body areas, or stimulation intensities, though specific dimensions should be confirmed with the manufacturer.

• What is the regulatory status of these electrodes?

  The device has received FDA 510(k) clearance with product code GZJ. It was reviewed by the Neurology advisory committee and determined to be substantially equivalent to predicate devices.