FDA.reportPublic FDA data

BIKO

Primary DI
08054040401916
Brand
BIKO
Company
ORMESA SRL
Model
BIKO SMALL ROSA 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
08054040401916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054040401916080540404019168054040401916

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
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
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA 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