FDA.reportPublic FDA data

DYNAMICO

Primary DI
08055715700884
Brand
DYNAMICO
Company
ORMESA SRL
Model
DYNAMICO-5 OUTDOOR USE
Device description
Walking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking.
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715700884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715700884080557157008848055715700884

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, non-foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist- or trunk-high, non-foldable framework with handgrips or hand-held frame and three or four legs, designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it might be used for rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials in the shape of a mobile support structure which the patient holds and pushes in front of them as they walk. It is non-foldable and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

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
true
Serial number
true
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040400612ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 NERO+951+8232026-09-06
08054040400629ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 ROSSO+951+8232026-09-06
08054040400636ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 ROSSO+951+8232026-09-06
08054040400643ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 NERO +951+8232026-09-06
08054040400650ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 NERO +951+8232026-09-06
08054040400667ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 ROSSO+951+8232026-09-06
08054040402074ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06
08054040402081ADJUSTABLE TROLLITROLLI REGOLABILE 40 NERO+823+9582026-09-06
08054040402098ADJUSTABLE TROLLITROLLI REGOLABILE 43 NERO+823+9582026-09-06
08054040402104ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 8632026-09-06
08054040402111ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 8632026-09-06
08054040402128ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 8632026-09-06
08054040402210ADJUSTABLE TROLLITROLLI REGOLABILE 36 ROSSO+823+9582026-09-06
08054040402227ADJUSTABLE TROLLITROLLI REGOLABILE-36 NERO 951,8632026-09-06
08054040402234ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 951,8632026-09-06
08054040402241ADJUSTABLE TROLLITROLLI REGOLABILE-40 NERO 951,8632026-09-06
08054040402258ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 951,8632026-09-06
08054040402265ADJUSTABLE TROLLITROLLI REGOLABILE-43 NERO 951,8632026-09-06
08054040402272ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 951,8632026-09-06
08054040402289ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975960550800noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-10-07
06975960550817noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-10-07
06973079880412SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDITJ2026-09-23
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