CONCOURSE ASSISTIVETECHNOLOGY PTY LTD
Basic Information
- Brand Name
- CONCOURSE ASSISTIVETECHNOLOGY PTY LTD
- Primary DI
- 93090019370034
- Version / Model
- M90
- Company Name
- CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD
- Labeler DUNS
- 748499503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-11
- Public Version
- 1
- Public Version Date
- 2025-03-19
- Public Version Status
- New
- Public Device Record Key
- 8e2ae863-52ee-45c3-9ada-5d863fc7a69d
Device Description
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42805 | Wheelchair electric-motor-driven propulsion system | An assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 93090019370034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242327 | 000 |