CORE PRODUCTS INTL., INC.

FDA Device Registration & Listing · OSCEOLA, WI, US · Registration 2183988

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
2183988
FEI Number
1000115743
Entity Name
CORE PRODUCTS INTL., INC.
City/State/Country
OSCEOLA, WI, US
Establishment Address
808 PROSPECT AVE., OSCEOLA, WI 54020, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Core Products International, Inc. (Owner Number: 9002815)
Owner / Operator Contact Address
808 Prospect Avenue, --, Osceola, WI 54020, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Swede-O Elastic Performance Sock, pair Swede-O Thermal Vent CT Immobilizer Swede-O Thermal Vent Wrist Forearm Splint Swede-O Thermal Vent CT Brace w/Thumb Spica Swede-O Thermal Vent Universal Thumb Spica Swede-O Thermal Vent Universal Wrist Wrap Swede-O Carpel Tunnel Glove Swede-O Thermal Vent Wrist Hand CT Brace Swede-O Dorsal Night Splint Swede-O Pediatric Walking Boot Swede-O Deluxe Night Splint Swede-O Adjustable Night Splint Swede-O Step Smart Swede-O Walking Boot, Tall Swede-O Walking Boot, Short CAST SHOE Swede-O Oped X8 Ankle Brace Swede-O Thermal Vent Ankle Foot Stabilizer Swede-O Thermal Vent Ankle Wrap Swede-O Trim Lok Ankle Brace Swede-O Thermal Vent Ankle Sleeve Swede-O Versi-Splint Swede-O Thermal Vent Therapeutic Foot Relief Swede-O Inner Lok 8 Ankle Brace Swede-O Thermal Vent Heel Rite Swede-O Elastic Ankle Swede-O Thermal Vent Plantar DR Swede-O Arch Lok Ankle Swede-O Strap Lok Ankle Brace Swede-O Ankle Lok Brace Swede-O Easy Lok Ankle Brace Swede-O Tarsal Lok Ankle Brace TRACTION UNIT Swede-O Thermal Vent Knee Patella Tracker Swede-O Thermal Vent Knee Sleeve Swede-O Thermal Vent Adjustable Knee Stabilizer Swede-O Thermal Vent Knee Stabilizer Swede-O Elastic Knee Support Swede-O Thermal Vent Knee Wrap Swede-O Thermal Vent Knee Patella Swede-O Elastic Knee Stabilizer Swede-O Elastic Knee Tetra-Stretch Swede-O Thermal Vent Open Wrap Hinged Knee Swede-O Thermal Vent Open Knee Wrap Stabilizer Swede-O Thermal Vent Open Wrap ROM Hinged Knee Breathable Body Shield Breathable Trochanter Foam Collars with vinyl straps Breathable Body Shield Foam Collars Posture Corrector Rib Belts Chest Cushion Peak Bolster Knee Elevator Dutchman Roll Deluxe Chest Cushion Half Round Bolster Fluffy Bolster 60" Body Pillow 60" Body Pillow Staphcheck Knee Bolster The M.A.T. Deluxe Knee Wedge LIMB TRUNCAL-ORTHOSIS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2017-05-24
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2017-05-23
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2006-10-18
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2017-05-23
IRS Head Halter, Traction Physical Medicine Class 1 890.5925 1992-07-22
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2010-12-15
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2016-07-25
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2006-09-21

Official Correspondent

Paul Norstrem

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Core Products International, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013770567 Therapeutica Canada ULC Ajax Ontario, CA
3008008970 Core Products International Inc Chetek, WI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183988. Last updated year: 2026. Please use registration number 2183988 when referencing this establishment in official correspondence.
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