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FDA 510(k)

INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR

K-Number: K060582 · 2006-03-16

ApplicantInvacare Corporation
Decision Date2006-03-16
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K060582. 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 INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR?

INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Invacare Corporation. The 510(k) number is K060582.

When did INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR receive FDA 510(k) clearance?

INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR received FDA 510(k) clearance on 2006-03-16, under 510(k) number K060582.

Who is the listed applicant for INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR?

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 TOPAZ BARIATRIC MANUAL WHEELCHAIR?

The FDA product code for INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR is IOR.

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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.

K203210Invacare Platinum 5NXG Oxygen ConcentratorK202379Invacare AVIVA Storm RX Power ChairK200890Invacare Perfecto2V Oxygen ConcentratorK192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPK191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityK182946Invacare TDX SP2-HD with Captain's Seat

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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

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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