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FDA 510(k)

GAZELLE WHEELCHAIR

K-Number: K020536 · 2002-03-15

ApplicantAlum Creek Wheelchair Co., Inc.
Decision Date2002-03-15
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GAZELLE WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Alum Creek Wheelchair Co., Inc.. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K020536. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAZELLE WHEELCHAIR?

GAZELLE WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Alum Creek Wheelchair Co., Inc.. The 510(k) number is K020536.

When did GAZELLE WHEELCHAIR receive FDA 510(k) clearance?

GAZELLE WHEELCHAIR received FDA 510(k) clearance on 2002-03-15, under 510(k) number K020536.

Who is the listed applicant for GAZELLE WHEELCHAIR?

The FDA 510(k) record lists Alum Creek Wheelchair Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAZELLE WHEELCHAIR?

The FDA product code for GAZELLE WHEELCHAIR is IOR.

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Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply 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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