FDA Registration
Active
🇺🇸 United States
Invacare Tracer SX5 Manual Wheelchair
Reg #: 1531186
·
FEI: 3002889431
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INVACARE CORP. DBA INVACARE AMERICA
- Registration Number
- 1531186
- FEI Number
- 3002889431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ONE INVACARE WAY
- City
- ELYRIA
- State
- OH
- ZIP
- 44035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162621
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, Mechanical | IOR | Class 1 | Physical Medicine | No | 2017-04-27 |
Proprietary Names
Invacare Tracer SX5 Manual Wheelchair
Invacare Tracer SX5 Recline Manual Wheelchair
Invacare Tracer IV Heavy Duty Manual Wheelchair
Invacare Tracer EX2 Wheelchair
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility