FDA 510(k)

TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR

K-Number: K802678 · 1980-12-10

ApplicantGeneral Medical Industries, Inc.

Decision Date1980-12-10

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Industries, Inc.. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802678. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR?

TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is General Medical Industries, Inc.. The 510(k) number is K802678.

When did TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802678.

Who is the listed applicant for TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR?

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

What is the FDA product code for TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR?

The FDA product code for TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR is GZJ.

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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.