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FDA 510(k)

Thermi Reusable Non-invasive RF Electrode

K-Number: K171094 · 2017-05-08

ApplicantThermgen, L.L.C
Decision Date2017-05-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermi Reusable Non-invasive RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Thermgen, L.L.C. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K171094. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermi Reusable Non-invasive RF Electrode?

Thermi Reusable Non-invasive RF Electrode is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Thermgen, L.L.C. The 510(k) number is K171094.

When did Thermi Reusable Non-invasive RF Electrode receive FDA 510(k) clearance?

Thermi Reusable Non-invasive RF Electrode received FDA 510(k) clearance on 2017-05-08, under 510(k) number K171094.

Who is the listed applicant for Thermi Reusable Non-invasive RF Electrode?

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

What is the FDA product code for Thermi Reusable Non-invasive RF Electrode?

The FDA product code for Thermi Reusable Non-invasive RF Electrode is GEI.

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Official Source

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