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FDA 510(k)

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

K-Number: K162621 · 2017-04-17

ApplicantInvacare Corporation
Decision Date2017-04-17
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide 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 2017-04-17 under 510(k) number K162621. 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 Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair?

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Invacare Corporation. The 510(k) number is K162621.

When did Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair receive FDA 510(k) clearance?

Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair received FDA 510(k) clearance on 2017-04-17, under 510(k) number K162621.

Who is the listed applicant for Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide 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 Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair?

The FDA product code for Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair is IOR.

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.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical 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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