FDA.reportPublic FDA data

STANDY

Primary DI
08055715705094
Brand
STANDY
Company
ORMESA SRL
Model
STANDY-4 large
Device description
Vertical standing frame for the acquisition and maintenance of an upright position and the training of the antigravity muscles of young, adult or elderly who cannot acquire and maintain them independently. Indicated for persons with functional deficits in verticalization and in maintaining an upright position, who have a minimum residual control of the trunk and head; users suffering from pathologies with alteration and impairment of the residual postural control, in which the load on the lower limbs is allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation.
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
08055715705094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715705094080557157050948055715705094

GMDN Terms#

Term, Definition table
TermDefinition
Manual standerA manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.

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