CONCOURSE ASSISTIVETECHNOLOGY PTY LTD

GUDID 93090019370034

The M90 is a medical device that allows a user to add a powered option to a manual wheelchair. The design intent is to be as non-intrusive and easy to integrate with a manual wheelchair as possible. This has myriad benifits to the end user, such as a sleek and subtle design with wireless operation, expedient configuration by the dealer/ocupational therapist, and ability to add a powered option to a wheelchair that the user is familiar with. The M90 is intended to be used to provide power assistance to manual wheelchair users who are limited in their field of activities because of their physical conditions. It is designed to augment or replace the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. The M90 will be used by: • Wheelchair Occupant • Carer • Therapist • Technician and Installer • Sales Personnel

CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD

Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 93090019370034
• NIH Device Record Key: 8e2ae863-52ee-45c3-9ada-5d863fc7a69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCOURSE ASSISTIVETECHNOLOGY PTY LTD
• Version Model Number: M90
• Company DUNS: 748499503
• Company Name: CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	93090019370034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242327

FDA Product Code

• ITI: Wheelchair, Powered

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: 2025-03-19
• Device Publish Date: 2025-03-11