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FDA 510(k)

HOVEROUND TEKNIQUE, MODEL HD-6

K-Number: K100527 · 2010-03-26

ApplicantHoveround Corp.
Decision Date2010-03-26
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND TEKNIQUE, MODEL HD-6 is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 2010-03-26 under 510(k) number K100527. 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 TEKNIQUE, MODEL HD-6?

HOVEROUND TEKNIQUE, MODEL HD-6 is a medical device that received FDA 510(k) clearance on 2010-03-26. The listed applicant is Hoveround Corp.. The 510(k) number is K100527.

When did HOVEROUND TEKNIQUE, MODEL HD-6 receive FDA 510(k) clearance?

HOVEROUND TEKNIQUE, MODEL HD-6 received FDA 510(k) clearance on 2010-03-26, under 510(k) number K100527.

Who is the listed applicant for HOVEROUND TEKNIQUE, MODEL HD-6?

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 TEKNIQUE, MODEL HD-6?

The FDA product code for HOVEROUND TEKNIQUE, MODEL HD-6 is ITI.

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Related Devices (Code: ITI)

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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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