FDA Registration
Active
🇺🇸 United States
SURESTEP, LLC
Reg #: 3003895329
·
FEI: 3003895329
·
Expires 2026
Products
6
Proprietary Names
4
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- SURESTEP, LLC
- Registration Number
- 3003895329
- FEI Number
- 3003895329
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17530 DUGDALE DR
- City
- South Bend
- State
- IN
- ZIP
- 46635
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203134
Owner / Operator
- Firm Name
- SURESTEP, LLC
- Operator Number
- 10028081
- Address
- 17530 DUGDALE DR
- City
- South Bend
- State
- IN
- Postal Code
- 46635
- Country
- US
- Correspondent
- SUZI KLIMEK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2008-12-29 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2016-09-27 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2011-10-10 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2014-03-28 |
| Orthosis, Cranial | MVA | Class 2 | Neurology | No | 2025-01-23 |
| Orthosis, Cranial, Laser Scan | OAN | Class 2 | Neurology | No | 2025-01-23 |
Proprietary Names
Surestep
SURESTEP
SureStep TLSO
CUSTOM MOLDED FOOT ORTHOSIS
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device