Balance™ Foot S Torsion
by Össur Iceland ehf. 456 variants
Ref BST0524LModel BU00051
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Balance Foot S Torsion is a revolutionary foot device designed to promote proper foot alignment and balance. By providing precise control over the torsional forces acting on the foot, it helps alleviate symptoms of conditions such as plantar fasciitis, Achilles tendonitis, and other foot disorders.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00051NA 05690967961787 | Date27 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BU00051, BST0524L
- Primary DI / UDI-DI
- 05690967961787
- Basic UDI-DI
- 5690967BU00051NA
- EMDN Code
- Y062403 Foot partial prostheses (including toe prostheses)
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No