Invacare® TDX® SP2 Power Wheelchair +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170507

Identifiers

510(k) Number: K170507 FDA 510(k)
FDA Product Code: ITI FDA 510(k)
Models / Variants: Invacare® TDX® SP2 Power Wheelchair FDA 510(k)
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 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.3860 FDA 510(k)
Regulation Number: 890.3860 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Invacare® TDX® SP2 Power Wheelchair +1 more model by Invacare Corporation — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K170507	Class II	Active

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Manufacturer

Manufacturer: Invacare Corporation

Sources (1)

FDA 510(k) K170507 24 fields · synced Jun 18, 2026