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FDA 510(k)

HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2

K-Number: K093946 · 2010-03-22

ApplicantHoveround Corp.
Decision Date2010-03-22
Product CodeILK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 2010-03-22 under 510(k) number K093946. The device is classified under product code ILK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2?

HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 is a medical device that received FDA 510(k) clearance on 2010-03-22. The listed applicant is Hoveround Corp.. The 510(k) number is K093946.

When did HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 receive FDA 510(k) clearance?

HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 received FDA 510(k) clearance on 2010-03-22, under 510(k) number K093946.

Who is the listed applicant for HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2?

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 HOVERGLIDE MODEL HOVERGLIDE MK-2?

The FDA product code for HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 is ILK.

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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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