Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001967835

FEI Number

3001967835

Entity Name

BOSTON BRACE INTERNATIONAL, INCORPORATED

City/State/Country

Stoughton, MA, US

Establishment Address

37 Shuman Ave, Stoughton, MA 02072, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

BOSTON BRACE INTERNATIONAL, INCORPORATED (Owner Number: 9051057)

Owner / Operator Contact Address

37 Shuman Ave, --, Stoughton, MA 02072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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) Boston Brace RC Boston Overlap Brace (BOB) Boston Brace 3D Boston Soft Spinal Orthosis (SSO) Boston Original Boston Night Shift Boston Body Jacket Boston Baby Boston Kyphosis Brace OPSB Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2004-01-05
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2023-09-11
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2024-12-11
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2004-01-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2009-02-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-06-30
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2004-01-05
NHF	Monitor, Orthotic/Prosthetic	Physical Medicine	Class 1	890.3025	2024-12-11

Official Correspondent

Thomas Morrissey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BOSTON BRACE INTERNATIONAL, INCORPORATED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3010884328	SCOLICARE	Kogarah New South Wales, AU
3009562727	Eckart KLOBE	Mannheim Baden-Wurttemberg, DE
3016426850	COFOE MEDICAL TECHNOLOGY CO.,LTD	Changsha Hunan, CN
3012453117	TREND MEDICAL, LLC	Bethlehem, PA, US
1226318	SPINAL TECHNOLOGY, LLC	West Yarmouth, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001967835. Last updated year: 2026. Please use registration number 3001967835 when referencing this establishment in official correspondence.