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FDA 510(k)

ELITE ELECTROMED L.I.T.E. 4/1

K-Number: K053507 · 2006-03-15

ApplicantElite Electromedical
Decision Date2006-03-15
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELITE ELECTROMED L.I.T.E. 4/1 is the device name listed in this FDA 510(k) record. The listed applicant is Elite Electromedical. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K053507. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE ELECTROMED L.I.T.E. 4/1?

ELITE ELECTROMED L.I.T.E. 4/1 is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Elite Electromedical. The 510(k) number is K053507.

When did ELITE ELECTROMED L.I.T.E. 4/1 receive FDA 510(k) clearance?

ELITE ELECTROMED L.I.T.E. 4/1 received FDA 510(k) clearance on 2006-03-15, under 510(k) number K053507.

Who is the listed applicant for ELITE ELECTROMED L.I.T.E. 4/1?

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

What is the FDA product code for ELITE ELECTROMED L.I.T.E. 4/1?

The FDA product code for ELITE ELECTROMED L.I.T.E. 4/1 is NHN.

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Related Devices (Code: NHN)

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

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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