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FDA 510(k)

HOVEROUND SE-3 POWERCHAIR

K-Number: K042920 · 2004-12-03

ApplicantHoveround Corp.
Decision Date2004-12-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND SE-3 POWERCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042920. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOVEROUND SE-3 POWERCHAIR?

HOVEROUND SE-3 POWERCHAIR is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Hoveround Corp.. The 510(k) number is K042920.

When did HOVEROUND SE-3 POWERCHAIR receive FDA 510(k) clearance?

HOVEROUND SE-3 POWERCHAIR received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042920.

Who is the listed applicant for HOVEROUND SE-3 POWERCHAIR?

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

What is the FDA product code for HOVEROUND SE-3 POWERCHAIR?

The FDA product code for HOVEROUND SE-3 POWERCHAIR is ITI.

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Other records listing Hoveround Corp. as applicant

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Related Devices (Code: ITI)

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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