Data / Medical devices / United States / Boston Brace International, Incorporated
Boston Brace International, Incorporated: FDA-registered device maker in Stoughton, MA, United States, 1 510(k) clearance
Boston Brace International, Incorporated is registered with the FDA (registration 3001967835) in Stoughton, MA, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 22, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3001967835
- Address
- 37 Shuman Ave, Stoughton, MA, United States, 02072
- Owner or operator
- BOSTON BRACE INTERNATIONAL, INCORPORATED (9051057)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 5, 2004
- Registered through
- 2026
- Brand names listed
- Ankle Foot Orthosis (AFO), Boston Baby, Boston Band Orthosis, Boston Body Jacket, Boston Brace 3D, Boston Brace RC, Boston Kyphosis Brace, Boston Night Shift and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Orthotic/Prosthetic | NHF | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial | MVA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2011 | K111609 | BOSTON BAND | MVA | Substantially Equivalent | Boston Brace Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Cranial
- All makers of Monitor, Orthotic/Prosthetic
- All makers of Orthosis, Limb Brace
- All makers of Joint, Ankle, External Brace
- All makers of Orthosis, Thoracic
- All makers of Orthosis, Lumbar
Updated August 22, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.