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FDA 510(k)

XTERRA GT POWER WHEELCHAIR

K-Number: K012909 · 2001-10-24

ApplicantInvacare Corp.
Decision Date2001-10-24
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

XTERRA GT POWER WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K012909. 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 XTERRA GT POWER WHEELCHAIR?

XTERRA GT POWER WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Invacare Corp.. The 510(k) number is K012909.

When did XTERRA GT POWER WHEELCHAIR receive FDA 510(k) clearance?

XTERRA GT POWER WHEELCHAIR received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012909.

Who is the listed applicant for XTERRA GT POWER WHEELCHAIR?

The FDA 510(k) record lists Invacare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTERRA GT POWER WHEELCHAIR?

The FDA product code for XTERRA GT POWER WHEELCHAIR is ITI.

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Other records listing Invacare 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.

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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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