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FDA 510(k)

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

K-Number: K010431 · 2001-09-06

ApplicantLead-Lok, Inc.
Decision Date2001-09-06
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Lead-Lok, Inc.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K010431. 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 LEAD-LOK REUSABLE TENS/ NMES ELECTRODES?

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Lead-Lok, Inc.. The 510(k) number is K010431.

When did LEAD-LOK REUSABLE TENS/ NMES ELECTRODES receive FDA 510(k) clearance?

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES received FDA 510(k) clearance on 2001-09-06, under 510(k) number K010431.

Who is the listed applicant for LEAD-LOK REUSABLE TENS/ NMES ELECTRODES?

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

What is the FDA product code for LEAD-LOK REUSABLE TENS/ NMES ELECTRODES?

The FDA product code for LEAD-LOK REUSABLE TENS/ NMES ELECTRODES is GXY.

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Other records listing Lead-Lok, Inc. as applicant

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Related Devices (Code: GXY)

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Official Source

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