FDA Registration
Active
🇺🇸 United States
Gel Wrist Wrap
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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-05-20 |
Proprietary Names
Gel Wrist Wrap
Auerbach Mallet Splint
TKO The Knuckle Orthosis
CMC Controller Plus
SANTA BARBARA THUMB
MODABBERTHUMB
MODABBER WRIST
SQUEEZE ULNAR COMPRESSION WRAP
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device