FDA 510(k)

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE

K-Number: K911366 · 1991-09-27

ApplicantMedical Design & Manufacturing Corp.

Decision Date1991-09-27

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K911366. 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 PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE?

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K911366.

When did PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE receive FDA 510(k) clearance?

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE received FDA 510(k) clearance on 1991-09-27, under 510(k) number K911366.

Who is the listed applicant for PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE?

The FDA 510(k) record lists Medical Design & Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE?

The FDA product code for PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE is GXY.

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Other records listing Medical Design & Manufacturing Corp. as applicant

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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.