FDA.reportPublic FDA data

OBI

Primary DI
08055715704561
Brand
OBI
Company
ORMESA SRL
Model
OBI-4 RUOTE NON ESTRAIBILI
Device description
Obi is a pushchair suitable for users with important functional impairments, with little or no control of the head and trunk, with little or no functional capacity, who need a particularly robust structure to be used mainly outdoors.
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715704561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715704561080557157045618055715704561

GMDN Terms#

Term, Definition table
TermDefinition
Assistive pushchairA wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432070019
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040402029FRAME RUNNERFRAME RUNNER SMALL 2R24’’ 1R20’’2025-10-15
08054040402036FRAME RUNNERFRAME RUNNER SMALL 3R20’’2025-10-15
08054040401275FRAME RUNNER"FRAME RUNNER MEDIUM FISS.3R24"""2025-09-20
08054040401282FRAME RUNNER"FRAME RUNNER LARGE FISS.3R26"" "2025-09-20
08054040401299FRAME RUNNERFRAME RUNNER MEDIUM RIBALT.3R24 2025-09-20
08054040401305FRAME RUNNERFRAME RUNNER LARGE RIBALT.3R262025-09-20
08054040401312FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R24""1R20"""2025-09-20
08054040401329FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R24""1R20"""2025-09-20
08054040401336FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R26""1R24"""2025-09-20
08054040401343FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R26""1R24"""2025-09-20
08054040401350FRAME RUNNERFRAME RUNNER LARGE FISS.3R242025-09-20
08054040401367FRAME RUNNERFRAME RUNNER LARGE RIB.3R242025-09-20
08054040401374FRAME RUNNER"FRAME RUNNER LARGE FISS.2R26""1R24"""2025-09-20
08054040401381FRAME RUNNER"FRAME RUNNER LARGE RIB.2R26""1R24"""2025-09-20
08054040401398FRAME RUNNER"FRAME RUNNER LARGE FISS.2R24""1R26"""2025-09-20
08054040401404FRAME RUNNER"FRAME RUNNER LARGE RIB.2R24""1R26"""2025-09-20
08054040401411FRAME RUNNER"FRAME RUNNER LARGE FISS.2R28""1R26"""2025-09-20
08054040401428FRAME RUNNER"FRAME RUNNER LARGE RIB.2R28""1R26"""2025-09-20
08054040401435FRAME RUNNERFRAME RUNNER LARGE FISS.3R282025-09-20
08054040401442FRAME RUNNERFRAME RUNNER LARGE RIB.3R282025-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408784ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408791ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408807ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00841447116479Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116486Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116493Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116509Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116516Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116523Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00193489028754GUARDIANMEDLINE INDUSTRIES, INC.INM2026-04-02
00884389150835MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150802MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150819MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408357ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408364ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408371ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408388ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408395ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408401ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408418ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408425ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408432ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408449ConvaidCONVAID PRODUCTS, INC.INM2026-02-05