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FDA 510(k)

EXTREME 4X4-X8 POWER WHEELCHAIR

K-Number: K090350 · 2009-04-10

ApplicantVestil Manufacturing Corp.
Decision Date2009-04-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXTREME 4X4-X8 POWER WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Vestil Manufacturing Corp.. It received FDA 510(k) clearance on 2009-04-10 under 510(k) number K090350. 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 EXTREME 4X4-X8 POWER WHEELCHAIR?

EXTREME 4X4-X8 POWER WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2009-04-10. The listed applicant is Vestil Manufacturing Corp.. The 510(k) number is K090350.

When did EXTREME 4X4-X8 POWER WHEELCHAIR receive FDA 510(k) clearance?

EXTREME 4X4-X8 POWER WHEELCHAIR received FDA 510(k) clearance on 2009-04-10, under 510(k) number K090350.

Who is the listed applicant for EXTREME 4X4-X8 POWER WHEELCHAIR?

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

What is the FDA product code for EXTREME 4X4-X8 POWER WHEELCHAIR?

The FDA product code for EXTREME 4X4-X8 POWER WHEELCHAIR is ITI.

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Other records listing Vestil Manufacturing 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.

K030783FRONTIER MODEL X5K021866KARMA 800 SERIES MANUAL WHEELCHAIRK014127KARMA DISCOVERY, MODEL KP40K011374JEWEL MPSK000796MAGIC MOBILITY 4 X 4 WHEELCHAIR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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