FDA.reportPublic FDA data

INVACARE® FDX® POWER WHEELCHAIR

Primary DI
00841447101284
Brand
INVACARE® FDX® POWER WHEELCHAIR
Company
INVACARE CORPORATION
Model
ATO_FDX-CG
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
K991168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991168000ARROW FWD POWER WHEELCHAIRInvacare Corp.1999-06-25ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841447101284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447101284008414471012848414471012840841447101284

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
00841447197966INVACARE® DLX SERIES BED RAILIH6803AIH6803A2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEIHCSTSPDIHCSTSPD2026-09-22
00841447198086Invacare® AspiratorIRC1135IRC11352026-09-22
00841447198093Invacare® Element™ Pneumatic ConserverIOC100PIOC100P2026-09-22
00841447199953INVACARE® BAR600 BARIATRIC BEDBAR600IVCBAR600IVC2026-09-21
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR18BM61PSR18B2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR18RM61PSR18R2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR20RM61PSR20R2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR20BM61PSR20B2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61RM61R2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61M612026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR16BM61PSR16B2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR16RM61PSR16R2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRATO_M61ATO_M612026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRATO_M61RATO_M61R2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRP31BLUEP31BLUE2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRP31BLACKP31BLACK2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGAIRPTMBDY18AIRPTMBDY182026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGAIRPTMBDY20AIRPTMBDY202026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRATO_M91-TSATO_M91-TS2026-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198260INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198277INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198284INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198291INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198307INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198314INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198321INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198338INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198345INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198352INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198369INVACARE® 3G STORM SERIES® ARROW® POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198376INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198383INVACARE® 3G STORM SERIES® TORQUE™ SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198390INVACARE® TDX® SR POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198406INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20