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FDA 510(k)

Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP

K-Number: K192216 · 2020-01-02

ApplicantInvacare Corporation
Decision Date2020-01-02
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K192216. 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 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP?

Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Invacare Corporation. The 510(k) number is K192216.

When did Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP receive FDA 510(k) clearance?

Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP received FDA 510(k) clearance on 2020-01-02, under 510(k) number K192216.

Who is the listed applicant for Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP?

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

What is the FDA product code for Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP?

The FDA product code for Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP is ITI.

Other records listing Invacare Corporation 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.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology 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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