203-5 SHOWER CHAIR

GUDID 08055715702833

Push wheelchair intended for the personal hygiene operations of users with disabilities, , semi-self-sufficient or non-self-sufficient users with poor head and trunk control, tending to lose contact with the surface of the backrest and slide with the pelvis forward and who assistance assistance in the care and hygiene of their own person to maintain stability and safety for the user and the assistant.

ORMESA SRL

Shower seat, non-powered

• Primary Device ID: 08055715702833
• NIH Device Record Key: 61ef57d4-7653-4eac-bbb3-8196c2c89f63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 203-5 SHOWER CHAIR
• Version Model Number: 203-5 SHOWER CHAIR
• 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	08055715702833 [Primary]

FDA Product Code

• INM: Chair, With Casters

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: 2025-02-10
• Device Publish Date: 2025-01-31

Devices Manufactured by ORMESA SRL

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• 08054040401299 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able
• 08054040401305 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able
• 08054040401312 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able
• 08054040401329 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able
• 08054040401336 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able
• 08054040401343 - FRAME RUNNER: 2025-09-29 The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able