Reusable Tens Paravertebral Pad #641 Back Electrod

• • Terminated Z-0498-2013 FDA Class II ·initiated 9 Feb 2012

  Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

510(k) Number

K901575 ↗

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 Pioneering Technologies, Inc. →

• What is the Reusable TENS Paravertebral Pad #641 Back Electrode used for?

  This device is a reusable transcutaneous electrical nerve stimulation (TENS) electrode designed specifically for application over the paravertebral region of the back. It is intended to deliver electrical stimulation as part of a TENS unit system, helping manage pain or facilitate neuromodulation in clinical settings. The electrode connects to a TENS unit to provide therapeutic electrical currents to the skin surface.

• Is the Reusable TENS Paravertebral Pad #641 Back Electrode sterile?

  No, the Reusable TENS Paravertebral Pad #641 Back Electrode is not sterile. It is supplied in a packaged form as a single-use electrode but is designed for reusable clinical applications with proper cleaning and maintenance between uses. Sterility is not required for reusable electrodes intended for this purpose.

• How is the Reusable TENS Paravertebral Pad #641 Back Electrode supplied?

  The electrode is supplied as a single-use package, though the device itself is reusable. Each package contains one electrode intended for clinical use. After use, the electrode must be cleaned and maintained according to manufacturer guidelines to ensure proper functionality for subsequent applications.

• Can this electrode be reused in a clinical setting?

  Yes, this electrode is explicitly designed for reusable clinical applications. However, reuse requires thorough cleaning and maintenance to prevent contamination or degradation of performance. The manufacturer’s instructions should be followed to ensure safe and effective repeated use.

• What regulatory clearance does the Reusable TENS Paravertebral Pad #641 Back Electrode hold?

  The device holds FDA 510(k) clearance under product code GXY, classified as an Electrode, Cutaneous. The clearance was granted on May 2, 1990, and it was determined to be substantially equivalent to a predicate device. This clearance applies to its use as part of a TENS unit system for pain management or neuromodulation.