Devices (same UDI-DI)
30
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00810080701021
- Basic UDI-DI Code
- 00810080701902-SMOTR
- Reference
- 1902-SMO-10y
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Surestep, LLC
Additional Description
The Surestep Go! SMO is designed to manage excessive mild to severe pronation associated with hypotonia. This SMO uses circumferential compression to stabilize the foot and ankle. The open heel allows more of the foot to “feel the floor”, which aids in sensory input and posture. For maximum function, this SMO should always be worn with shoes. For Shoe Size: 10Y, Orientation: Right/Left
CND Nomenclature Codes
| Code | Description |
|---|---|
| Y06120601 | PASSIVE ANKLE-FOOT ORTHOSES |
Related Devices
The Basic UDI-DI associated with this device has 30 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Surestep
Device
EU MDR
·
Eu Md Class 1
·Surestep, LLC·On the market
Surestep
Device
EU MDR
·
Eu Md Class 1
·Surestep, LLC·On the market
Surestep
Device
EU MDR
·
Eu Md Class 1
·Surestep, LLC·On the market
Surestep
Device
EU MDR
·
Eu Md Class 1
·Surestep, LLC·On the market
Surestep
Device
EU MDR
·
Eu Md Class 1
·Surestep, LLC·On the market
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