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FDA 510(k)

EMPI ISLAND TENS ELECTRODE

K-Number: K890605 · 1989-03-16

ApplicantEmpi
Decision Date1989-03-16
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMPI ISLAND TENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K890605. 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 EMPI ISLAND TENS ELECTRODE?

EMPI ISLAND TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Empi. The 510(k) number is K890605.

When did EMPI ISLAND TENS ELECTRODE receive FDA 510(k) clearance?

EMPI ISLAND TENS ELECTRODE received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890605.

Who is the listed applicant for EMPI ISLAND TENS ELECTRODE?

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

What is the FDA product code for EMPI ISLAND TENS ELECTRODE?

The FDA product code for EMPI ISLAND TENS ELECTRODE is GXY.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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Related Devices (Code: GXY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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