FDA Registration
Active
🇺🇸 United States
Heelbo
Reg #: 3010694026
·
FEI: 3010694026
·
Expires 2025
Products
1
Proprietary Names
41
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BREG, INC.
- Registration Number
- 3010694026
- FEI Number
- 3010694026
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2835 Fortune Cir W
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Owner / Operator
- Firm Name
- Breg Inc
- Operator Number
- 10041297
- Address
- 2382 Faraday Avenue, Suite 300
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Monique Zamora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2012-08-17 |
Proprietary Names
Heelbo
Axiom Ankle
Integrity Walker
Mid-Calf Boot
Achilles Boot
ProGait
J Walker
Flatform Boot
Bunion Boot
Ultimate Ankle
AdjustaFit Boot
Wee Walker
Hi Top / Lo Top
Boot Cover
Ankle Quick Wrap
Conformer
Charcot Conformer
Wraptor
Plantar Fasciitis Splint
Performance Knit Ankle
Ankle Elastic Support
Ankle Lace up
Ankle Brace Lock (ABL)
Ankle Stirrup
VersaStrap Ankle
Multi-Stay Ankle
Shell Ankle Walker
KoolAir Ankle
Controlled ROM Walker
Ankle Walker
Boot Acsy Kit Extension Strap
Ultra Ankle
Pin Cam Walker
Ankle Sprain Kit
Mini Walker
Silicone Elastic Ankle Support
Vectra Walker
Accessories - Cuff Kit, Bootie, Pads, Air Bladder, Straps
Vectra Pro Walker
Achilles Wedge
Vectra Wee Walker
Establishment Types
Repack or Relabel Medical Device