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FDA 510(k)

HOVEROUND POWER WHEELCHAIR, MODEL HD700

K-Number: K042033 · 2004-09-29

ApplicantHoveround Corp.
Decision Date2004-09-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND POWER WHEELCHAIR, MODEL HD700 is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 2004-09-29 under 510(k) number K042033. 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 POWER WHEELCHAIR, MODEL HD700?

HOVEROUND POWER WHEELCHAIR, MODEL HD700 is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Hoveround Corp.. The 510(k) number is K042033.

When did HOVEROUND POWER WHEELCHAIR, MODEL HD700 receive FDA 510(k) clearance?

HOVEROUND POWER WHEELCHAIR, MODEL HD700 received FDA 510(k) clearance on 2004-09-29, under 510(k) number K042033.

Who is the listed applicant for HOVEROUND POWER WHEELCHAIR, MODEL HD700?

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 POWER WHEELCHAIR, MODEL HD700?

The FDA product code for HOVEROUND POWER WHEELCHAIR, MODEL HD700 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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