Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00810080701052
- Basic UDI-DI Code
- 00810080701907-SMO-SSS8
- Reference
- 1907-SMO-SS
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Surestep, LLC
Additional Description
The Surestep SMO (supramalleolar orthosis) revolutionized orthotic management for children with hypotonia. Through the use of extremely thin, flexible thermoplastic, the Surestep SMO compresses the soft tissues of the foot with its patented design; stabilizing children while still allowing for natural development. Surestep SMOs are carefully marked as ‘left’ and ‘right’ so the unique compression system can work its magic. Our products help to stabilize the foot and relieve stress on ankles, knees and hips so your child can grow and develop as a happy and healthy kid.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Y06120601 | PASSIVE ANKLE-FOOT ORTHOSES |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).
ORTHODONTIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·LEONE S.P.A.·On the market·32 countries
Catalyst 5
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 4
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 5VX
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Spark
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Clik
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market