MedtechSourcebook

SURESTEP, LLC

Contract manufacturer ยท South Bend, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3003895329 (openFDA record; or search FDA's registration database)
FEI number
3003895329
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
SURESTEP, LLC (FDA owner/operator no. 10028081)
Registered address
17530 DUGDALE DR, South Bend, IN 46635
Contract listings
1 device listings, 1 product codes, first listed Mar 28, 2014
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
KNPOrthosis, Corrective ShoeClass IPhysical medicineContract manufacturingMar 28, 2014