Eu Mdr
Eu Md Class 1
On The Market
🇺🇸 United States
Surestep
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00810080701113
- Basic UDI-DI Code
- 0810080701970-PUL-SSW8
- Reference
- 1970-PUL-SS
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Surestep, LLC
Additional Description
Our Surestep Pullover facilitates improved stability of the foot and ankle by working alongside the Surestep SMO. The Pullover incorporates a true dorsiflexion assist through the use of a removable proximal strut. This allows our product to be whatever your child needs. The Pullover is able to be used as a Surestep SMO to start, and then as a free-motion, dorsiflexion assist AFO when needed. This makes our Pullover the perfect solution for children with mild hemiplegia who need that little bit of extra help to get on the right path.
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