FDA Registration
Active
🇺🇸 United States
Hely & Weber
Reg #: 3014154030
·
FEI: 3014154030
·
Expires 2026
Products
8
Proprietary Names
57
Establishment Types
2
Classifications
8
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Registration Details
- Registration Name
- Hely & Weber
- Registration Number
- 3014154030
- FEI Number
- 3014154030
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 755 Regent Blvd, Suite 250
- City
- DFW
- State
- TX
- ZIP
- 75261
- Country
- US
Owner / Operator
- Firm Name
- HELY AND WEBER
- Operator Number
- 9033906
- Address
- 1185 EAST MAIN ST., --
- City
- Santa Paula
- State
- CA
- Postal Code
- 93060
- Country
- US
- Correspondent
- John P Hely
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-11-01 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2023-11-01 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2023-11-01 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-11-01 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2023-11-01 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-11-01 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2023-11-01 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-05-20 |
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
Twin V
Double Back LSO
Clavicle Splint
SUEDE LACING WRIST
CONTROLLER PLUS
XTENDER®
CAST-AWAY® FRACTURE ORTHOSIS
deQ® THUMB ORTHOSIS
PHOMFIT WHT ORTHOSIS
TFO® - THE FRACTURE ORTHOSIS
TITAN WRIST
MTC FRACTURE BRACE®
HANDCUFF®
TITAN THUMB
FingerFix
HFix Orthosis
Liga-Loc
CMC Controller Plus
TKO The Knuckle Orthosis
Gel Wrist Wrap
SANTA BARBARA THUMB
MODABBER WRIST
TKO® 2 - The Knuckle Orthosis
MODABBERTHUMB
CMC Controller Pro
SQUEEZE ULNAR COMPRESSION WRAP
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device