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FDA 510(k)

Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

K-Number: K170507 · 2017-07-12

ApplicantInvacare Corporation
Decision Date2017-07-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K170507. 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® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx?

Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Invacare Corporation. The 510(k) number is K170507.

When did Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx receive FDA 510(k) clearance?

Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx received FDA 510(k) clearance on 2017-07-12, under 510(k) number K170507.

Who is the listed applicant for Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx?

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® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx?

The FDA product code for Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx is ITI.

Related Clinical Trials

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Other records listing Invacare Corporation as applicant

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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: 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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