FDA.reportPublic FDA data

Invacare Essentials SX3

Primary DI
00841447114802
Brand
Invacare Essentials SX3
Company
INVACARE CORPORATION
Model
ISX386DAEL
Catalog number
ISX386DAEL
Device description
Essential SX3 18 x 16 Desk Arms Elevating Legrests
Published
2024-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052468000YK9000 SERIES MANUAL WHEELCHAIRIntco Metal Products (Zhenjiang) Co., Ltd.2005-10-05IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841447114802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447114802008414471148028414471148020841447114802

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(440)329-6000orders@invacare.com
(440) 329-6000orders@invacareamerica.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
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
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13
00841447116387Easy Glide Wheelchair for InvacareEGWC20STRSBUEGWC20STRSBU2026-02-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868262050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31