FDA Registration
Active
🇺🇸 United States
GELrod Elbow
Reg #: 3014154030
·
FEI: 3014154030
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Hely & Weber
- Registration Number
- 3014154030
- FEI Number
- 3014154030
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-11-01 |
Proprietary Names
GELrod Elbow
UNIV SLING AND SWATHE
GUS SHOULDER IMMOBILIZING SLING
Cubital Comfort Brace
SHOULDER HOULDER II
UNIVERSAL SHOULDER IMMOBILIZER
Gus Arm Sling
VAPOR IMMOBILIZATION SLING
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device