OPSB Sensor

Basic Information

• Brand Name: OPSB Sensor
• Primary DI: 00860013109806
• Version / Model: SENSOR-V1
• Company Name: Boston Brace International, Inc.
• Labeler DUNS: 801816158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-21
• Public Version: 1
• Public Version Date: 2025-03-03
• Public Version Status: New
• Public Device Record Key: cd9e7370-b7e6-4175-91ec-15bf940ce3e6

Device Description

OPSB Sensor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHF	Monitor, Orthotic/Prosthetic	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62169	Wireless patient monitor/sensor reporting software, layperson-use	A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013109806	GS1