FDA.report

MINI STANDY

Primary DI
08055715705438
Brand
MINI STANDY
Company
ORMESA SRL
Model
MINI STANDY - 1
Device description
Standing frame intended for users suffering from pathologies with alteration and impairment of the residual functional capacity of 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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INMChair, With Casters

Product Code Classifications

CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055715705438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055715705438080557157054388055715705438

GMDN Terms

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

Regulatory Flags

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08054040401350FRAME RUNNERFRAME RUNNER LARGE FISS.3R242025-09-20
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08054040401381FRAME RUNNERFRAME RUNNER LARGE RIB.2R26"1R24"2025-09-20
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08054040401404FRAME RUNNERFRAME RUNNER LARGE RIB.2R24"1R26"2025-09-20
08054040401411FRAME RUNNERFRAME RUNNER LARGE FISS.2R28"1R26"2025-09-20
08054040401428FRAME RUNNERFRAME RUNNER LARGE RIB.2R28"1R26"2025-09-20
08054040401435FRAME RUNNERFRAME RUNNER LARGE FISS.3R282025-09-20
08054040401442FRAME RUNNERFRAME RUNNER LARGE RIB.3R282025-09-20
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