FDA Registration
Active
🇺🇸 United States
TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
Reg #: 1525712
·
FEI: 1525712
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INVACARE CORP. DBA INVACARE AMERICA
- Registration Number
- 1525712
- FEI Number
- 1525712
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1200 Taylor St
- City
- ELYRIA
- State
- OH
- ZIP
- 44035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170507
Owner / Operator
- Firm Name
- Invacare Corporation
- Operator Number
- 1525712
- Address
- One Invacare Way
- City
- Elyria
- State
- OH
- Postal Code
- 44035
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2017-07-18 |
Proprietary Names
TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
TDXSP2 TDX® SP2 with LiNX Electronics
Invacare® TDX® SP2 Power Wheelchair
Invacare® TDX SP2 with Motion Concepts Ultra Low Maxx Power Positioning
TDXSP2V: TDX SP2 with Captains Seat
TDXSP2-CG TDX® SP2 Base for Single Actuator System w/ Ultra Low Maxx
Establishment Types
Manufacture Medical Device