Valutrode Neurostimlation Electrodes

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

510(k) Number

K130987 ↗

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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• Pals Platinum Neurostimulation Electrodes

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• Ultrastim Kit

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• Ultrastim Electrode, Model US4040

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• Transcutaneous Electric Nerve Stimulation (Tens)

  Class II

  FDA 510(k) K874469 Active Cleared 28 Jan 1988

• Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D

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  FDA 510(k) K080580 Active Cleared 18 Jun 2008

See all devices from Axelgaard Mfg. Co., Ltd. →

• What is the primary purpose of Valutrode Neurostimulation Electrodes?

  These electrodes are designed for neurostimulation applications. They utilize a specialized lead wire interface and MultiStick hydrogel to ensure effective current distribution across the skin surface during treatment.

• What material options are available for these electrodes?

  Valutrode electrodes are available in various configurations to suit different clinical needs, specifically offering both cloth and foam top options.

• What is the regulatory status of this device?

  Valutrode Neurostimulation Electrodes have received FDA 510k clearance under the K130987 submission, confirming they have been found substantially equivalent to legally marketed predicate devices.