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FDA 510(k)

HOVEROUND TEKNIQUE

K-Number: K122741 · 2013-05-07

ApplicantHoveround Corp.
Decision Date2013-05-07
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND TEKNIQUE is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 2013-05-07 under 510(k) number K122741. 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?

HOVEROUND TEKNIQUE is a medical device that received FDA 510(k) clearance on 2013-05-07. The listed applicant is Hoveround Corp.. The 510(k) number is K122741.

When did HOVEROUND TEKNIQUE receive FDA 510(k) clearance?

HOVEROUND TEKNIQUE received FDA 510(k) clearance on 2013-05-07, under 510(k) number K122741.

Who is the listed applicant for HOVEROUND TEKNIQUE?

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?

The FDA product code for HOVEROUND TEKNIQUE is ITI.

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Other records listing Hoveround Corp. as applicant

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.

K122707HOVERROUND TEKNIQUEK100527HOVEROUND TEKNIQUE, MODEL HD-6K100350HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GTK093946HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2K090108HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIRK043069HOVEROUND E100 POWER CHAIR

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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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