THE HYGENIC COMPANY, LLC

FDA Device Registration & Listing · Akron, OH, US · Registration 1519375

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
1519375
FEI Number
1519375
Entity Name
THE HYGENIC COMPANY, LLC
City/State/Country
Akron, OH, US
Establishment Address
1245 HOME AVE., Akron, OH 44310, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
The Hygenic Company, LLC (Owner Number: 1519375)
Owner / Operator Contact Address
1245 Home Ave, Akron, OH 44310, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KQW Goniometer, Nonpowered Orthopedic Class 1 888.1520 2020-11-25
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2017-03-14
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2016-10-31
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2025-12-29
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2021-12-02
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2021-12-02
EIE Dam, Rubber Dental Class 1 872.6300 1977-11-15
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2017-10-24
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2019-08-26
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 1995-09-05
MDR Binder, Medical, Therapeutic General Hospital Class 1 880.5160 2021-12-02
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2018-11-02

Official Correspondent

Melanie Leibowitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Hygenic Company, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9681338 The Hygenic Corporation Batu Gajah Perak, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K040797 Britesmile, Inc. BRITESMILE MASKING CREAM 2004-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1519375. Last updated year: 2026. Please use registration number 1519375 when referencing this establishment in official correspondence.
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