BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THE HYGENIC COMPANY, LLC

    Reg #: 1519375 · FEI: 1519375 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    103
    Establishment Types
    4
    Classifications
    20

    Registration Details

    Registration Name
    THE HYGENIC COMPANY, LLC
    Registration Number
    1519375
    FEI Number
    1519375
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1245 HOME AVE.
    City
    Akron
    State
    OH
    ZIP
    44310
    Country
    US

    Owner / Operator

    Firm Name
    The Hygenic Company, LLC
    Operator Number
    1519375
    Address
    1245 Home Ave
    City
    Akron
    State
    OH
    Postal Code
    44310
    Country
    US
    Correspondent
    Melanie - Leibowitz

    Products

    Device Name Product Code
    Goniometer, Nonpowered KQW
    Joint, Ankle, External Brace ITW
    Tape And Bandage, Adhesive KGX
    Massager, Therapeutic, Manual LYG
    Joint, Knee, External Brace ITQ
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Dam, Rubber EIE
    Pack, Hot Or Cold, Disposable IMD
    Bandage, Cast ITG
    Tourniquet, Nonpneumatic GAX
    Binder, Medical, Therapeutic MDR
    Pack, Hot Or Cold, Reusable IME
    Solvent, Adhesive Tape KOX
    Bandage, Elastic FQM
    Exerciser, Non-Measuring ION
    Orthosis, Limb Brace IQI
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Components, Exercise IOD
    Bag, Ice KYR
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ

    Proprietary Names

    Finger/Toe Goniometer Active Ankle T2 Eclipse II Active Ankle 329 Heel-Lock Ankle Support Active Ankle 325 Dual Strap Support Excel Multi-Phase Active Ankle AS1 Pro Pro-Lacer Neoprene Ankle Support TheraBand Kinesiology Tape Cramer AT Pro Athletic Tape Cramer 1050i Athletic Sports Tape Cramer Team Colors Athletic Trainer's Tape Cramer 950 Athletic Trainer's Tape All Sports Athletic Tape Retail Cramer 750 Athletic Trainer's Tape Rolyan Reach Massager TheraCane Massager Basic Patellar Support Knee Support Patellar Tendon Strap Patellar Support Diamond Knee Stabilizer Medco-Pateller Sleeve Medco-Knee Sleeve Rapid Form Vacuum Immobilizer Moldable Thumb Spica Dorsal Night Splint Flexi Dam Non-Latex Framed Flexi Dam Non-Latex NON-LATEX DENTAL DAM Rubber Dam Elasti-Dam Fiesta Dental Dam HYGENIC DENTAL DAM Cramer Instant Cold Pack Sammons Preston Pain Control Care Kit Horseshoe Pads, Dual Density Foam BD Stretch Tourniquet Strap Hygenic Hysynal Tourniquet Strap Deluxe Back Stabilizer Back support Groin strain support Cold Shoulder Wrap Cramer Tape Remover Underwrap Tape EcoFlex Stretch Tape Self-Stick Tape Bulk HYSNAL TheraBand Sheeting Latex (includes Loops and High Resistance) (all configurations) TheraBand Tubing TheraBand Hand Xtrainer TheraBand Hand Trainer TheraBand Stability Trainer TheraBand Stability Disk TheraBand Standard Roller Massager TheraBand Aquafins Aquatic Exercise Kit TheraBand Rocker Boards TheraBand Flexbar TheraBand Portable Roller Massager TheraBand Hand Bar with Padded Grip TheraBand Soft Weights TheraBand Exercise Balls TheraBand Exercise Station TheraBand Webbed Pull Buoy Swim Training Aid TheraBand Stretch Strap TheraBand Wobble Boards TheraBand Swim Bar with Padded Grip TheraBand Hand Exerciser TheraBand Mini Ball TheraBand Roller Wraps TheraBand Shoulder Pulley Young Swim Belt with High-Density Buoyancy Foam TheraBand Foot Roller TheraBand Kickroller Floatation Device with Padded Grip TheraBand Closed Chain Buoyancy Disk TheraBand Sheeting Non-Latex TheraBand Half Round Roller Round Roller (12" and 36") CLX Station Anchors Rolyan Exercise Band Rolyan Door Anchor Stirrup Rolyan Exercise Tubing Theraband Therapy Putty Rolyan Therapy Putty Theraband Anchor Rolyan Ergonomic Hand Exerciser Wrist and Thumb Stabilizer Shoulder Stabilizer Thigh Support Medco Calf Support Medco Elbow Support Medco Thigh Sleeve Wrist Wrap Trigger Finger Elbow Support Shin Splint Sleeve Tennis Elbow Strap COTTON TIPPED APPLICATORS Ankle and Wrist Weights (Blue, Green, Red) Cramer Ice Bags Accessory Leg Strap

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device