FDA.report

BIKO

Primary DI
08055715709283
Brand
BIKO
Company
ORMESA SRL
Model
BIKO XL ROSSO 864 DIFF.PIGN.FISSO
Device description
Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system.
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
IONExerciser, Non-Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055715709283PrimaryGS10

GMDN Terms

TermDefinition
Assistive foot-propelled tricycleA vehicle with three wheels mounted on a slender frame which the user with a disability sits astride and pedals with their legs to provide a means of transportation, typically without the attendance of another person. It is designed to be operated by the user. The vehicle will enhance the user's independence in short- to medium-range transportation.

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

Primary DIBrandModelCatalogPublished
08054040401275FRAME RUNNERFRAME RUNNER MEDIUM FISS.3R24"2025-09-20
08054040401282FRAME RUNNERFRAME 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 RUNNERFRAME RUNNER MEDIUM FISS.2R24"1R20"2025-09-20
08054040401329FRAME RUNNERFRAME RUNNER MEDIUM RIB.2R24"1R20"2025-09-20
08054040401336FRAME RUNNERFRAME RUNNER MEDIUM FISS.2R26"1R24"2025-09-20
08054040401343FRAME RUNNERFRAME 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 RUNNERFRAME RUNNER LARGE FISS.2R26"1R24"2025-09-20
08054040401381FRAME RUNNERFRAME RUNNER LARGE RIB.2R26"1R24"2025-09-20
08054040401398FRAME RUNNERFRAME RUNNER LARGE FISS.2R24"1R26"2025-09-20
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
08054040402432GRILLO GRILLO SMALL ANT.PA (809 MINI IBR.)2025-09-15
08054040402449GRILLO GRILLO SMALL ANT.P PELV.MINI IBRID2025-09-15

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