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FDA 510(k)

TENS/NMES/FES STIMULATING ELECTRODE

K-Number: K083350 · 2009-04-21

ApplicantCovidien LP
Decision Date2009-04-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS/NMES/FES STIMULATING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Covidien LP. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K083350. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS/NMES/FES STIMULATING ELECTRODE?

TENS/NMES/FES STIMULATING ELECTRODE is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Covidien LP. The 510(k) number is K083350.

When did TENS/NMES/FES STIMULATING ELECTRODE receive FDA 510(k) clearance?

TENS/NMES/FES STIMULATING ELECTRODE received FDA 510(k) clearance on 2009-04-21, under 510(k) number K083350.

Who is the listed applicant for TENS/NMES/FES STIMULATING ELECTRODE?

The FDA 510(k) record lists Covidien LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS/NMES/FES STIMULATING ELECTRODE?

The FDA product code for TENS/NMES/FES STIMULATING ELECTRODE is GXY.

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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