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FDA 510(k)

QUANTUM BARIATRIC 451

K-Number: K112815 · 2012-02-29

ApplicantPride Mobility Product Corporration
Decision Date2012-02-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

QUANTUM BARIATRIC 451 is the device name listed in this FDA 510(k) record. The listed applicant is Pride Mobility Product Corporration. It received FDA 510(k) clearance on 2012-02-29 under 510(k) number K112815. 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 QUANTUM BARIATRIC 451?

QUANTUM BARIATRIC 451 is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Pride Mobility Product Corporration. The 510(k) number is K112815.

When did QUANTUM BARIATRIC 451 receive FDA 510(k) clearance?

QUANTUM BARIATRIC 451 received FDA 510(k) clearance on 2012-02-29, under 510(k) number K112815.

Who is the listed applicant for QUANTUM BARIATRIC 451?

The FDA 510(k) record lists Pride Mobility Product Corporration as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTUM BARIATRIC 451?

The FDA product code for QUANTUM BARIATRIC 451 is ITI.

Related Clinical Trials

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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Other records listing Pride Mobility Product Corporration 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.

K113488JAZZY ELITE 6

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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