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FDA 510(k)

HOVEROUND E100 POWER CHAIR

K-Number: K043069 · 2004-12-03

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

Device Summary

HOVEROUND E100 POWER CHAIR 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 K043069. 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 E100 POWER CHAIR?

HOVEROUND E100 POWER CHAIR 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 K043069.

When did HOVEROUND E100 POWER CHAIR receive FDA 510(k) clearance?

HOVEROUND E100 POWER CHAIR received FDA 510(k) clearance on 2004-12-03, under 510(k) number K043069.

Who is the listed applicant for HOVEROUND E100 POWER CHAIR?

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 E100 POWER CHAIR?

The FDA product code for HOVEROUND E100 POWER CHAIR 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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