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FDA 510(k)

KM-30 TENS ELECTRODE

K-Number: K010543 · 2001-05-23

ApplicantKatecho, Inc.
Decision Date2001-05-23
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KM-30 TENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 2001-05-23 under 510(k) number K010543. 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 KM-30 TENS ELECTRODE?

KM-30 TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Katecho, Inc.. The 510(k) number is K010543.

When did KM-30 TENS ELECTRODE receive FDA 510(k) clearance?

KM-30 TENS ELECTRODE received FDA 510(k) clearance on 2001-05-23, under 510(k) number K010543.

Who is the listed applicant for KM-30 TENS ELECTRODE?

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

What is the FDA product code for KM-30 TENS ELECTRODE?

The FDA product code for KM-30 TENS ELECTRODE is GXY.

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Other records listing Katecho, Inc. as applicant

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Related Devices (Code: GXY)

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Official Source

View on FDA Database →

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

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