FDA.reportPublic FDA data

BIKO

Primary DI
08054040401923
Brand
BIKO
Company
ORMESA SRL
Model
BIKO MEDIUM BLU DIFFERENZ.SWITCH
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
2026-08-01
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

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054040401923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054040401923080540404019238054040401923

GMDN Terms#

Term, Definition table
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.

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
08054040401879BIKOBIKO MINI ROSSO SWITCH LIB./FISSO2026-08-01
08054040401886BIKOBIKO MINI ROSA SWITCH LIB./FISSO2026-08-01
08054040401893BIKOBIKO SMALL BLU DIFFERENZ.SWITCH2026-08-01
08054040401909BIKOBIKO SMALL ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401916BIKOBIKO SMALL ROSA DIFFERENZ.SWITCH2026-08-01
08054040401930BIKOBIKO MEDIUM ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401947BIKOBIKO MEDIUM VERDE DIFFERENZ.SWITCH2026-08-01
08054040401954BIKOBIKO LARGE BLU DIFFERENZ.SWITCH2026-08-01
08054040401961BIKOBIKO LARGE ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401978BIKOBIKO LARGE VERDE DIFFERENZ.SWITCH2026-08-01
08054040401985BIKOBIKO XL BLU DIFFERENZ.SWITCH2026-08-01
08054040401992BIKOBIKO XL ROSSO DIFFERENZ.SWITCH2026-08-01
08054040402005BIKOBIKO XL VERDE DIFFERENZ.SWITCH2026-08-01
08054040402135BUGBUG-S UNITA'SED.SENZA TAPPEZZER.192026-08-01
08054040402142BUGBUG-M UNITA'SED.SENZA TAPPEZZER.192026-08-01
08054040402548GRILLOGRILLO SMALL ANT.PT(PELV./MINI)IBR2026-08-01
08054040402876BIKOBIKO SMALL ROSSO RUOTA LIBERA2026-08-01
08054040403729BIKOBIKO XL BLU 864 DIFF.RUOTA LIBERA SU MISURA2026-08-01
08055715702949BUGBUG SMALL 869 NARROW BASE (black), LIGHT GREY GREE2026-08-01
08055715702956BUGBUG SMALL 869 NARROW BASE (black), DARK GREY GREEN2026-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
18018294018006AirFeel IMTFLAEM NUOVA SPAION2026-02-18
00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
08054040401275FRAME RUNNERORMESA SRLION2025-09-20
08054040401282FRAME RUNNERORMESA SRLION2025-09-20
08054040401299FRAME RUNNERORMESA SRLION2025-09-20
08054040401305FRAME RUNNERORMESA SRLION2025-09-20
08054040401312FRAME RUNNERORMESA SRLION2025-09-20
08054040401329FRAME RUNNERORMESA SRLION2025-09-20
08054040401336FRAME RUNNERORMESA SRLION2025-09-20