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FDA 510(k)

EMSI GARMENT ELECTRODES

K-Number: K090889 · 2009-12-04

ApplicantEmsi
Decision Date2009-12-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMSI GARMENT ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Emsi. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K090889. 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 EMSI GARMENT ELECTRODES?

EMSI GARMENT ELECTRODES is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Emsi. The 510(k) number is K090889.

When did EMSI GARMENT ELECTRODES receive FDA 510(k) clearance?

EMSI GARMENT ELECTRODES received FDA 510(k) clearance on 2009-12-04, under 510(k) number K090889.

Who is the listed applicant for EMSI GARMENT ELECTRODES?

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

What is the FDA product code for EMSI GARMENT ELECTRODES?

The FDA product code for EMSI GARMENT ELECTRODES is GXY.

Related Clinical Trials

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Other records listing Emsi 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.

K102202GS 3000K090717FLEX-TENSK083030TENS-EMS-14K071869TENS/IF 14

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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