FDA.reportPublic FDA data

Ocean Ergo Dir. Lock VA

Primary DI
04028698133363
Brand
Ocean Ergo Dir. Lock VA
Company
INVACARE CORPORATION
Model
1641078
Catalog number
1641078
Device description
Ocean Ergo Dir. Lock VA
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
INNCHAIR, ADJUSTABLE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04028698133363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04028698133363040286981333634028698133363

GMDN Terms#

Term, Definition table
TermDefinition
Basic toilet seatA seat intended to be attached to a toilet bowl or toilet chair to provide conventional position, stability, and/or comfort to a seated occupant while toileting.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
076916246
Device count
1
Premarket exempt
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
00840456224656JMUJMU DENTAL, INCINN2026-10-09
00840456224663JMUJMU DENTAL, INCINN2026-10-09
00840456224670JMUJMU DENTAL, INCINN2026-10-09
00840456224687JMUJMU DENTAL, INCINN2026-10-09
00840456224694JMUJMU DENTAL, INCINN2026-10-09
00840456224700JMUJMU DENTAL, INCINN2026-10-09
00840456224717JMUJMU DENTAL, INCINN2026-10-09
00840456224724JMUJMU DENTAL, INCINN2026-10-09
00840456224731JMUJMU DENTAL, INCINN2026-10-09
00850039103414StaxiStaxi CorporationINN2026-07-21
00850039103452StaxiStaxi CorporationINN2026-07-21
00850039103346StaxiStaxi CorporationINN2026-07-20
00850039103353StaxiStaxi CorporationINN2026-07-20
00850039103360StaxiStaxi CorporationINN2026-07-20
00850039103421StaxiStaxi CorporationINN2026-07-20
05715393055838R82R82 A/SINN2026-03-26
05715393078868R82R82 A/SINN2026-03-26
00860014545825Peri-Chair LLCPERI-CHAIR, LLCINN2025-10-15
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
05707581000751Shower SeatRopox A/SINN2022-12-08
05707581000768Shower SeatRopox A/SINN2022-12-08
05707581000775Shower SeatRopox A/SINN2022-12-08
05707581000782Shower SeatRopox A/SINN2022-12-08
07320451321794Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451321817Etac Supply Center ABEtac Supply Center ABINN2022-12-08
00850001752169Compass Chair Size 1RIFTON EQUIPMENTINN2022-09-16
00850001752176Compass Chair Size 2RIFTON EQUIPMENTINN2022-09-16