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Stimuplex Pen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061983

by Stockert GmbH

Identifiers

510(k) Number
K061983 FDA 510(k)
FDA Product Code
BXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2775 FDA 510(k)
Regulation Number
868.2775 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stimuplex Pen is an electrode for cutaneous stimulation that conducts electrical impulses when connected to the Stimuplex HNS 11 or HNS 12 nerve stimulator and placed on the skin. It initiates muscular contractions and/or synchronous electrical paresthesia within the distribution area of a nerve.

The device is supplied by Stockert GmbH and is FDA 510(k) cleared with product code BXN. It is a Class II device intended for use with nerve stimulators and is not specified as single-use or reusable. The device is not described as MRI safe and no storage conditions are provided in the data.

Frequently asked questions

What is the STIMUPLEX PEN used for?

The STIMUPLEX PEN is an electrode designed for cutaneous stimulation that conducts electrical impulses when connected to Stimuplex HNS 11 or HNS 12 nerve stimulators. It initiates muscular contractions and/or synchronous electrical paresthesia within the distribution area of a nerve.

Is the STIMUPLEX PEN single-use or reusable?

The device is not specified as single-use or reusable in the provided data. The STIMUPLEX PEN is a Class II device intended for use with nerve stimulators, but no specific information regarding its reusability is available.

What regulatory approvals does the STIMUPLEX PEN have?

The STIMUPLEX PEN is FDA 510(k) cleared with product code BXN. It was received by the FDA on July 13, 2006, with a decision date of November 21, 2006, and is classified as substantially equivalent. The device is intended for use in anesthesiology.

Is the STIMUPLEX PEN MRI safe?

The device is not described as MRI safe in the provided data. No specific information regarding MRI compatibility or safety is available in the device specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stockert GmbH, Stimuplex Pen 510 (k) FDA Premarket Notification K061983 STOCKERT GMBH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stockert GmbH

Sources (1)

  • FDA 510(k) K061983 24 fields · synced Sep 27, 2026