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

Surestep

Surestep, LLC · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
00810080701144
Basic UDI-DI Code
0810080700482-TLS-SSSP
Reference
0482-TLS-SS
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Surestep, LLC

Additional Description

Our TLSO helps to manage the growth of young children’s spines. By implementing our unique Surestep compression techniques, the TLSO creates improved upright positioning while still allowing for movement in all directions. By applying this compression more evenly around the torso, Surestep can provide more stability with less rigidity. Each TLSO can be modified to fit the kiddo’s specific needs. When required, the TLSO can be fabricated with an anterior or posterior opening and can be modified to accommodate any other medical needs. The Abdominal Cutout is designed to allow belly (or diaphragmatic) breathing. A gusset across the opening maintains compression while still allowing dynamic movement. The Lateral Gills allow lateral rib expansion in breathing. The Anterior Gill allows for anterior/superior chest expansion in breathing. Together, all three of these modifications allow triplanar breathing and support any combination of breathing patterns for each individual patient. A Surestep TLSO can include any combination of breathing modifications and still provide circumferential compression and support of the spine.

CND Nomenclature Codes

Code Description
Y060309 THORACOLUMBOSACRAL SPINE ORTHOSES

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