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FDA 510(k)

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP

K-Number: K173313 · 2018-02-13

ApplicantEurogreen International, Inc.
Decision Date2018-02-13
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP is the device name listed in this FDA 510(k) record. The listed applicant is Eurogreen International, Inc.. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K173313. 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 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Eurogreen International, Inc.. The 510(k) number is K173313.

When did SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP receive FDA 510(k) clearance?

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP received FDA 510(k) clearance on 2018-02-13, under 510(k) number K173313.

Who is the listed applicant for SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

The FDA 510(k) record lists Eurogreen International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

The FDA product code for SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP is ITI.

Other records listing Eurogreen International, Inc. 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.

K182631SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)K173315SupaChair Powered 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.

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

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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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