FDA.reportPublic FDA data

FRAME RUNNER

Primary DI
08054040401275
Brand
FRAME RUNNER
Company
ORMESA SRL
Model
FRAME RUNNER MEDIUM FISS.3R24"
Device description
The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able to run, who have sufficient awareness and perception of the space around them. It is suitable for people with severe motor and coordination difficulties who can use the Frame Runner as a therapeutic and recreational activity: its use improves fitness and strength as well as physical and emotional well-being. Even those who have difficulty controlling their balance while walking can benefit from the use of the Frame Runner thanks to the stability provided by the entire system.
Published
2025-09-20
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
08054040401275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054040401275080540404012758054040401275

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
08054040402432GRILLOGRILLO SMALL ANT.PA (809 MINI IBR.)2025-09-15
08054040402449GRILLOGRILLO SMALL ANT.P PELV.MINI IBRID2025-09-15
08054040402463GRILLOGRILLO SMALL ANT.(P/T COMP.MINI)IBR2025-09-15
08054040402470GRILLOGRILLO MEDIUM ANT.P(SMALL) IBRID.2025-09-15
08054040402487GRILLOGRILLO MED.POST.PT IBR(PEL.S/TOR.S)2025-09-15
08054040402494GRILLOGRILLO MED.POST.PT IBR(PEL.S)2025-09-15
08054040402500GRILLOGRILLO MED.POST.PA IBRID (PELV.S)2025-09-15
08054040402524GRILLOGRILLO MED.POST.PA IBR(PEL.S-BRAG.M2025-09-15
08054040402531GRILLOGRILLO SMALL ANT.PA(PEL/ANT.MIN)IBR2025-09-15
08054040402555GRILLOGRILLO SMALL ANT.PT(TOR./MINI)IBR2025-09-15
08054040402562GRILLOGRILLO SMALL POST.P PELV.MINI IBR2025-09-15
08054040402579GRILLOGRILLO SMALL POST.PA PELV.MINI IBR2025-09-15
08055715700105GRILLOGRILLO SMALL POSTERIORE PT2025-01-31
08055715700112GRILLOGRILLO SMALL POSTERIORE PA2025-01-31
08055715700129GRILLOGRILLO SMALL POSTERIORE P2025-01-31
08055715700136GRILLOGRILLO MEDIUM ANTERIORE PT2025-01-31
08055715700143GRILLOGRILLO MEDIUM ANTERIORE PA2025-01-31
08055715700150GRILLOGRILLO MEDIUM ANTERIORE P2025-01-31
08055715700167GRILLOGRILLO MEDIUM POSTERIORE PT2025-01-31
08055715700174GRILLOGRILLO MEDIUM POSTERIORE PA2025-01-31

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
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
00616784050119Pedal Exerciser, Folding, Hands/FeetDynarex CorporationION2025-05-29