FDA.reportPublic FDA data

INVACARE® TDX® POWER WHEELCHAIR

Primary DI
00841447100874
Brand
INVACARE® TDX® POWER WHEELCHAIR
Company
INVACARE CORPORATION
Model
TDXSP-CG-GT
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITIWheelchair, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023589000STORM TDX POWER WHEELCHAIRInvacare Corp.2002-11-19ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841447100874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100874008414471008748414471008740841447100874

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(440)329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841447114635Invacare® Platinum Oxygen ConcentratorIRC9LXO2AWQL5IRC9LXO2AWQL52026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorIRC5PO2VAWL5IRC5PO2VAWL52026-07-21
05600494139948Invacare Birdie Evo XPlus Full Body LiftBRDXPLUSBRDXPLUS2026-06-03
00841447116431Invacare® Alternating Air Mattress & PumpMA101BLMA101BL2026-05-01
00841447116448Invacare® Alternating Air Mattress & PumpMA101BKMA101BK2026-05-01
00841447116455Invacare® Alternating Air Mattress & Pump with Static ModeMA102BLMA102BL2026-05-01
00841447116462Invacare® Alternating Air Mattress & Pump with Static ModeMA102BKMA102BK2026-05-01
00841447116479Easy Glide Transport Chair for InvacareEGTC19STFSBUEGTC19STFSBU2026-04-10
00841447116486Easy Glide Transport Chair for InvacareEGTC19STFSBKEGTC19STFSBK2026-04-10
00841447116493Easy Glide Transport Chair for InvacareEGTC19STRSBUEGTC19STRSBU2026-04-10
00841447116509Easy Glide Transport Chair for InvacareEGTC19STRSBKEGTC19STRSBK2026-04-10
00841447116516Easy Glide Transport Chair for InvacareEGTC19ALRSBUEGTC19ALRSBU2026-04-10
00841447116523Easy Glide Transport Chair for InvacareEGTC19ALRSBKEGTC19ALRSBK2026-04-10
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13

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Primary DI, Brand, Company table
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