FDA Registration
Active
🇺🇸 United States
BOSTON BRACE INTERNATIONAL, INCORPORATED
Reg #: 3001967835
·
FEI: 3001967835
·
Expires 2026
Products
9
Proprietary Names
21
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- BOSTON BRACE INTERNATIONAL, INCORPORATED
- Registration Number
- 3001967835
- FEI Number
- 3001967835
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 37 Shuman Ave
- City
- Stoughton
- State
- MA
- ZIP
- 02072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111609
Owner / Operator
- Firm Name
- BOSTON BRACE INTERNATIONAL, INCORPORATED
- Operator Number
- 9051057
- Address
- 37 Shuman Ave, --
- City
- Stoughton
- State
- MA
- Postal Code
- 02072
- Country
- US
- Correspondent
- Thomas Morrissey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2004-01-05 |
| Orthosis, Cranial | MVA | Class 2 | Neurology | No | 2023-09-11 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2024-12-11 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2004-01-05 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2009-02-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-06-30 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2004-01-05 |
| Monitor, Orthotic/Prosthetic | NHF | Class 1 | Physical Medicine | No | 2024-12-11 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2004-01-05 |
Proprietary Names
Boston Brace 3D
Boston Brace RC
Boston Overlap Brace (BOB)
Boston Baby
Boston Soft Spinal Orthosis (SSO)
Boston Night Shift
Boston Body Jacket
Boston Original
Boston Kyphosis Brace
Boston Band Orthosis
OPSB Sensor Mobile App
OPSB Sensor Cloud Backend
OPSB Sensor Web Portal
University of California Berkley Orthosis (UCB)
Supramalleolar Orthosis (SMO)
Ankle Foot Orthosis (AFO)
Knee Ankle Foot Orthosis (KAFO)
Knee Orthosis (KO)
OPSB Sensor
Reciprocating Gait Orthosis (RGO)
Hip Knee Ankle Foot Orthosis (HKAFO)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device