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FDA 510(k)

DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS

K-Number: K870160 · 1987-04-01

ApplicantLa Jolla Technology, Inc.
Decision Date1987-04-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS is the device name listed in this FDA 510(k) record. The listed applicant is La Jolla Technology, Inc.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K870160. 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 DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS?

DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is La Jolla Technology, Inc.. The 510(k) number is K870160.

When did DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS receive FDA 510(k) clearance?

DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870160.

Who is the listed applicant for DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS?

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

What is the FDA product code for DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS?

The FDA product code for DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS is GXY.

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Other records listing La Jolla Technology, Inc. as applicant

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.

K864956DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.K854204DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENSK832888ECG INTERFERENCE FILTER TF-03K830932NYNEX II

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Official Source

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