FDA Registration
Active
🇦🇺 Australia
Sunrise medical (US)
Reg #: 3038189190
·
FEI: 3038189190
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD
- Registration Number
- 3038189190
- FEI Number
- 3038189190
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Hamley Road
- City
- Mt Kuring-Gai New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K242327
Owner / Operator
- Firm Name
- Concourse Assistive Technology PTY LTD
- Operator Number
- 10092945
- Address
- 9 Hamley Road
- City
- Mt Kuring-Gai
- State
- New South Wales
- Postal Code
- 2080
- Country
- AU
- Correspondent
- David MacKay
US Agent
- Business Name
- Sunrise Medical
- Contact Name
- Tanisha Gregory
- Address
- 12002 Volunteer Parkway
- City
- Mount Juliet
- State
- TN
- ZIP
- 37122
- Country
- US
- [email protected]
- Phone
- 800 3334000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2025-03-09 |
Proprietary Names
Sunrise medical (US)
Establishment Types
Manufacture Medical Device