Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014154030

FEI Number

3014154030

Entity Name

Hely & Weber

City/State/Country

DFW, TX, US

Establishment Address

755 Regent Blvd, Suite 250, DFW, TX 75261, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

HELY AND WEBER (Owner Number: 9033906)

Owner / Operator Contact Address

1185 EAST MAIN ST., --, Santa Paula, CA 93060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GK ORIGIN Knee Immobilizer UNIV. MATT STRAP II KNAPP HINGED KNEE VELOCITY PS ANTERIOR CLOSURE HINGED NEOP. KNEE KUHL KNAPP ANTERIOR KNEE SLEEVE SHIELDS® BRACE HINGED STAB. W/PAD Global Knee PAT-TRAC ECHO KNEE KNEESIO PATELLOFEMORAL BRACE SYNERGY HINGED KNEE SLEEVE TINY POST OP KNEE KUHL Lei-Back LONG ELBOW SLEEVE ORTHOWEAR ELBOW UNIVERSAL SHOULDER IMMOBILIZER Gus Arm Sling GUS SHOULDER IMMOBILIZING SLING UNIV SLING AND SWATHE Cubital Comfort Brace GELrod Elbow VAPOR IMMOBILIZATION SLING SHOULDER HOULDER II Rapid Zap Ankle Viseloc Air Ankle Stirrup Webly Zap Ankle Webly® Achilles TT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-11-01
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2023-11-01
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-11-01
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-11-01
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-11-01

Official Correspondent

John Hely

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HELY AND WEBER

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014154030. Last updated year: 2026. Please use registration number 3014154030 when referencing this establishment in official correspondence.