SURESTEP, LLC

FDA Device Registration & Listing · South Bend, IN, US · Registration 3003895329

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003895329
FEI Number
3003895329
Entity Name
SURESTEP, LLC
City/State/Country
South Bend, IN, US
Establishment Address
17530 DUGDALE DR, South Bend, IN 46635, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SURESTEP, LLC (Owner Number: 10028081)
Owner / Operator Contact Address
17530 DUGDALE DR, South Bend, IN 46635, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surestep SURESTEP Surestep Surestep SureStep TLSO CUSTOM MOLDED FOOT ORTHOSIS Surestep

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2008-12-29
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2016-09-27
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2011-10-10
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2014-03-28

Official Correspondent

SUZI KLIMEK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURESTEP, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003895329. Last updated year: 2026. Please use registration number 3003895329 when referencing this establishment in official correspondence.
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