FRAME RUNNER

GUDID 08054040401374

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.

ORMESA SRL

Assistive foot-propelled tricycle

• Primary Device ID: 08054040401374
• NIH Device Record Key: 60d921b7-53e2-4c73-a76c-e9fa13c14d66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRAME RUNNER
• Version Model Number: FRAME RUNNER LARGE FISS.2R26"1R24"
• Company DUNS: 432070019
• Company Name: ORMESA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054040401374 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-20

On-Brand Devices [FRAME RUNNER]

• 08054040401442: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401435: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401428: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401411: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401404: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401398: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401381: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401374: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401367: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401350: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401343: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401336: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401329: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401312: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401305: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401299: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401282: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho
• 08054040401275: The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids witho