Core Products International Inc

FDA Device Registration & Listing · Chetek, WI, US · Registration 3008008970

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
3008008970
FEI Number
3008008970
Entity Name
Core Products International Inc
City/State/Country
Chetek, WI, US
Establishment Address
1505 Parker Drive, Chetek, WI 54728, US
Establishment Type(s)
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 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 ROLYAN TAKEOFF GEL THUMB RT & LT Fits All Elbow Support Deluxe Neoprene Hinged Knee ROLYAN TAKEOFF THUMB SUP RT & LT Standard Neoprene Knee Support TAKEOFF THERAPEUTIC ELBOW BAND ROLYAN TAKEOFF CUST THUMB RT & LT ROLYAN TAKEOFF WRIST RT & LT Neoprene Elbow Support Neoprene Elbow Sleeve Slip on Elbow Support ROLYAN BUNION SPLINT RT & LT X Back Elastic Knee Brace Slip On Elastic Knee Brace Neoprene Knee Sleeve HiFlex Ankle Support Foot Flexor Ankle Foot Orthosis Swede-O Thermal Vent Calf Shin Swede-O Arthritic Gloves Pair Foot Flexor 15" Tensioner Swede-O Thermal Vent Neck Wrap Breathable Ankle Swede-O Thermal Vent Thigh Hamstring Zimmer Ankle Brace with Elastic Strap Swede-O Neoprene Slip on Knee Swede-O Front Close Knee Brace with Hinges Swede-O Reflex Wrist Support NelMed Beige Wrist Support Swede-O Patella Strap Swede-O Elastic Multi-Use Support Trident Osteoarthritis Knee Brace Swede-O Elastic Wrist Brace Swede-O Wraparound Neoprene Knee Support Swede-O Neoprene Open Patella Knee Sleeve Zimmer Canvas Ankle with Strap Swede-O Bi-Lateral Thumb Spica Splint NelMed Beige Tennis Elbow Support POWER WRAP WRIST POWER WRAP ANKLE PERFORMANCE WRAP Therapeutica Spinal Back Support Therapeutica Travel Sleeping Pillow Therapeutica Cervical Sleeping Pillow Lite Therapeutica Molded Lumbar Support Therapeutica Spinal Support Plus Therapeutica Cervical Sleeping Pillow Tri-Core Ultimate Cervical Support Pillow COMFORT PADS COMFORT BED PAD COMFORT WHEELCHAIR PADDING Micro Bead Pack Moist Heat pack Swede-O Joint Wrap Core Clover Pack Micro Bead Eye Compress APEX MOIST HEAT PACK MICROBEAD MOIST HEAT THERAPY MITT ThermalCore Moist Heat Packs NelMed Calf Urinary Bag Support NelMed Thigh Urinary Bag Support NelMed ARM NelMed G Tube Holder Breathable Wrap Soothe-A-Ciser Spinal Relief Pillow Body Shield Ab Binder-9" Molded Lumbar Bucketseat Cushion Basic Cervical Firm Bucket Sitback Rest Standard D-Core Body Shield Ab Binder-12" Lobak Rest AB Contour Satin Deluxe Knee Wedge Ladies Comfort Cushion Dual Pull Crisscross Peak Bolster Petite Core Printed Adult Pelvic Blocks Petite Core White Air-Core Adjustable Double Core Firm/X-Firm Cervitrac Gentle Sooth-A-Ciser Cotton/Poly Cover Slimrest Standard Firm Baby Hugger Single w/Extra underpant Knee Elevator Elastic Industrial Belt Ladies Comfort Cushion Deluxe Printed Sitback Rest Bed Wedge 10" Sitback Rest Deluxe Tri-Core Standard Multi Brace 627 CorFit Advantage Maternity Support Luniform Half Roll Sitback Rest w/ hot & cold pack Semi-Universal Trochanter Jackson Roll CorFit Industrial Belt Bucket Sitback Rest Deluxe Body Control Ab Binder-12" Sitback Mesh Backrest Core Memory Full-Size Leg Spacer Petite Baby Hugger Extra Underpant only Tri-Core Excel Standard Body Control Ab Binder-9" CervAlign 5" Leg Spacer Standard CorFit Belt Slimrest Deluxe Firm Econo Leg Spacer w/cover-Std. Tri-Core Comfort Zone-Std. CorFit Trochanter Hiback Rest, Large Cervical Roll, Soft Contoured CorBack w/Vinyl Pulls Multi Brace 637 Molded Lumbar Cushion Dutchman Roll Bolster 8 x 18 Canvasback Cervitrac Standard Sitback Plus Body Shield Trochanter Belt Foam Half Roll 12 x 2 1/2 Baby Hugger Single Sooth-A-Ciser Vinyl Cover Corebak Support Tri-Core Excel GentleStandard Stress Wedge Super Lift Adjustable Travel Roll Leg Spacer Econo Standard Core CPap Pillow-3" Mini Core Cpap Pillow-3.5" H Memory Face Cradle (Vinyl) Dutchman Roll Bolster 6 x 18 Fluffy Bolster Half Round 3 x 6 x 24 Elastic Trochanter Mid-Core Comfort Zone Fusion Comfort Core w/ Adj. Backrest Sooth-A-Ciser with Hot and Cold Pack Bed Wedge Tri-Core Gentle Travel Core Foam Roll 12 x 5 Mesh D-Roll Black Triple Pull Elastic Belt Sitback Rest Standard Ventilated Elastic Support Belt Sherpa Memory Face Cradle WondaWedge Triple Pull Elastic Belt w/pad Mid-Core Gentle Wraptor Body Shield Rib Belt Cervical Roll, Firm Bed Wedge 12" Inflatable Backrest Core Memory Mid-Size Sitback Plus II Snuggle Foam Cervical Pillow Apex Cervical Adjustable Orthosis Snuggle Memory Foam Body Pillow Snuggle Foam Travel Pillow Swede-O Elastic Back Stabilizer Swede-O Thermal Vent Lumbar Support Therapeutica Bucket seat Lumbar Support Cushion Swede-O Thermal Vent LSO Rib Belt Therapeutica Lumbar Support Cushion THERAPEUTICA CERVICAL SLEEPING PILLOW LITE Apex Cervical Orthosis Premium Apex Cervical Orthosis Premium with Heat Teardrop Pillow Memory Air-Core Memory Plus Perfect Rest Therapeutica Orthopedic Sleeping Pillow Spine Saver Wedge Luniform Bowtie Pillow Symphy Support Hibak Rest Double Core Select Lil' Lift Better Binder Econo-Wave Headache Ice Pillow Comfort Core Backrest Max-Relax Face Cushion PowerWrap Corfit Belt CerviLoft Adjustable Cervical Comfort Pillow Tri-Core Natural Cervical Pillow Gentle Support Adjusta-Loft Fiber Comfort Pillow Tri-Core Natural Cervical Pillow Standard Support The Original Wonder Disc Sleep Log Pillow Swede-O Joint Wrap Core Clover Pack CORPAK HEAT WHEAT PACKS 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 Hernia Aid Breathable Posture Support Trochanter Belt with Double Pull 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 Traction Table Knee Bolster Head Halter Traction Table Accessory Kit Pelvic Sacral Block 9" Abdominal Binder Breathable Body Shield Breathable Body Control 12" Abdominal Binder BREATHABLE POSTURE SUPPORT Dr. Kennedy's Neck Deck Pivotal Health Traction Harness Traction Harness System Universal Traction Harness Therapist Thumb Swede-O Plantar F3 Foot Roller Omni Suspensory Narrow Waist Athletic Supporter Wide Waist Athletic Supporter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2017-05-23
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2006-09-21
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2016-05-16
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2006-10-18
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2010-12-21
FQM Bandage, Elastic General Hospital Class 1 880.5075 2006-10-18
ILI Sling, Arm Physical Medicine Class 1 890.3640 2006-09-21
IQG Adaptor, Holder, Syringe Physical Medicine Class 1 890.5050 2010-12-20
KMO Binder, Elastic General Hospital Class 1 880.5160 2010-12-15
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2010-12-15
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 1992-07-22
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2006-09-21
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2017-05-23
EXN Support, Hernia Gastroenterology, Urology Class 1 876.5970 2013-03-20
IPW Orthosis, Sacroiliac, Soft Physical Medicine Class 1 890.3490 2016-07-25
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2010-12-15
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2010-12-15
FSD Binder, Abdominal General Hospital Class 1 880.5160 2010-12-15
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2016-07-18
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2010-12-15
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2010-12-15
FQJ Support, Scrotal, Therapeutic General Hospital Class 1 880.5820 2010-12-15

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
2183988 CORE PRODUCTS INTL., INC. OSCEOLA, WI, US

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 3008008970. Last updated year: 2026. Please use registration number 3008008970 when referencing this establishment in official correspondence.
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