FDA.reportPublic FDA data

BIKO

Primary DI
08055715709122
Brand
BIKO
Company
ORMESA SRL
Model
BIKO LARGE VERD.PIGN.FISS0
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
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
IONExerciser, Non-Measuring

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715709122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715709122080557157091228055715709122

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
08054040402036FRAME RUNNERFRAME RUNNER SMALL 3R20’’2025-10-15
08055715708583BIKOBIKO MINI ROSA PIGN.FISS02025-01-31
08055715708590BIKOBIKO MINI ROSA RUOTA LIBERA2025-01-31
08055715708668BIKOBIKO SMALL ROSA DIFF.PIGN.FISS02025-01-31
08055715708675BIKOBIKO SMALL ROSA DIFF.RUOTA LIBERA2025-01-31
08055715708682BIKOBIKO SMALL ROSA PIGN.FISS02025-01-31
08055715708699BIKOBIKO SMALL ROSA RUOTA LIBERA2025-01-31
08055715708880BIKOBIKO MEDIUM VERD.DIFF.CAMBIOeCONTR.2025-01-31
08055715708897BIKOBIKO MEDIUM VERD.DIFF.PIGN.FISS02025-01-31
08055715708903BIKOBIKO MEDIUM VERD.DIFF.RUOTA LIBERA2025-01-31
08055715708910BIKOBIKO MEDIUM VERD.PIGN.FISS02025-01-31
08055715708927BIKOBIKO MEDIUM VERD.RUOTA LIBERA2025-01-31
08055715708934BIKOBIKO MEDIUM VERD.864 DIFF.PIGN.FISS2025-01-31
08055715708941BIKOBIKO MEDIUM VERD.864 DIFF.RUOTA LIB2025-01-31
08055715709023BIKOBIKO LARGE ROSSO DIFF.CAMBIOeCONTR.2025-01-31
08055715709085BIKOBIKO LARGE ROSSO 864 DIFF.RUOTA LIB2025-01-31
08055715709092BIKOBIKO LARGE VERD.DIFF.CAMBIOeCONTROP2025-01-31
08055715709108BIKOBIKO LARGE VERD.DIFF.PIGN.FISS02025-01-31
08055715709115BIKOBIKO LARGE VERD.DIFF.RUOTA LIBERA2025-01-31
08055715709139BIKOBIKO LARGE VERD.RUOTA LIBERA2025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08054040401343FRAME RUNNERORMESA SRLION2025-09-20
08054040401350FRAME RUNNERORMESA SRLION2025-09-20
08054040401367FRAME RUNNERORMESA SRLION2025-09-20
08054040401374FRAME RUNNERORMESA SRLION2025-09-20
08054040401381FRAME RUNNERORMESA SRLION2025-09-20
08054040401398FRAME RUNNERORMESA SRLION2025-09-20
08054040401404FRAME RUNNERORMESA SRLION2025-09-20
08054040401411FRAME RUNNERORMESA SRLION2025-09-20
08054040401428FRAME RUNNERORMESA SRLION2025-09-20
08054040401435FRAME RUNNERORMESA SRLION2025-09-20
08054040401442FRAME RUNNERORMESA SRLION2025-09-20
00384703160019EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703150010EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703155015EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00810188050557Vector BaseBioness Medical, Inc.ION2025-07-18
00616784050010Pedal Exerciser, Non-Folding, Hands/FeetDynarex CorporationION2025-05-29