Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

Surestep

Surestep, LLC · 🇺🇸 United States
Devices (same UDI-DI)
30
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
00810080701434
Basic UDI-DI Code
00810080701902-SMOTR
Reference
1902-SMO-10YL
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: Left

CND Nomenclature Codes

Code Description
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES

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The Basic UDI-DI associated with this device has 30 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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