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FDA 510(k)

TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE

K-Number: K851175 · 1985-06-18

ApplicantMedical Devices, Inc.
Decision Date1985-06-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1985-06-18 under 510(k) number K851175. 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE?

TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Medical Devices, Inc.. The 510(k) number is K851175.

When did TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE received FDA 510(k) clearance on 1985-06-18, under 510(k) number K851175.

Who is the listed applicant for TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE?

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

What is the FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE?

The FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE is GXY.

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Other records listing Medical Devices, Inc. as applicant

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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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