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FDA 510(k)

TEKNIQUE

K-Number: K010075 · 2001-02-14

ApplicantHoveround Corp.
Decision Date2001-02-14
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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 2001-02-14 under 510(k) number K010075. 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 TEKNIQUE?

TEKNIQUE is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Hoveround Corp.. The 510(k) number is K010075.

When did TEKNIQUE receive FDA 510(k) clearance?

TEKNIQUE received FDA 510(k) clearance on 2001-02-14, under 510(k) number K010075.

Who is the listed applicant for 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 TEKNIQUE?

The FDA product code for 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 TEKNIQUEK122741HOVEROUND TEKNIQUEK100527HOVEROUND TEKNIQUE, MODEL HD-6K100350HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GTK093946HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2K090108HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR

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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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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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