FDA.reportPublic FDA data

OPSB Sensor

Primary DI
00860013109806
Brand
OPSB Sensor
Company
Boston Brace International, Inc.
Model
SENSOR-V1
Device description
OPSB Sensor
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
NHFMonitor, Orthotic/Prosthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHFMonitor, Orthotic/ProstheticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013109806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013109806008600131098068600131098060860013109806

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient monitor/sensor reporting software, layperson-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801816158
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014460807Boston Body Jacket, Single OpeningBoston Body Jacket, Single OpeningBoston Body Jacket, Single Opening2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Body Jacket, Bivalve OpeningBoston Body Jacket, Bivalve Opening2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Overlap Brace (BOB)Boston Overlap Brace (BOB)2025-08-05
00860010708194Lower Limb OrthoticsUniversity of California Berkley Orthosis (UCB)2025-04-11
00860013109844Lower Limb OrthoticsSupramalleolar Orthosis (SMO)Supramalleolar Orthosis (SMO)2025-04-11
00860013109851Lower Limb OrthoticsAnkle Foot Orthosis (AFO)Ankle Foot Orthosis (AFO)2025-04-11
00860013109868Lower Limb OrthoticsKnee Orthosis (KO)Knee Orthosis (KO)2025-04-11
00860013109875Lower Limb OrthoticsKnee Ankle Foot Orthosis (KAFO)Knee Ankle Foot Orthosis (KAFO)2025-04-11
00860013109882Lower Limb OrthoticsHip Knee Ankle Foot Orthosis (HKAFO)Hip Knee Ankle Foot Orthosis (HKAFO)2025-04-11
00860013109899Lower Limb OrthoticsReciprocating Gait Orthosis (RGO)Reciprocating Gait Orthosis (RGO)2025-04-11
00860013109813OPSB Sensor Mobile AppSENSOR-MA-V12025-02-21
00860013109820OPSB Sensor Web PortalSENSOR-WP-V12025-02-21
00860013109837OPSB Sensor Cloud BackendSENSOR-CB-V12025-02-21
00860010708163Boston BraceBoston Brace Original Boston Original 2024-06-10
00860010708170Boston BraceBoston Brace RC Boston RC 2024-06-10
00860010708187Boston BraceBoston Brace BabyBoston Baby2024-06-10
00860010708118Boston BraceScoliosis: Boston 3D-Finished BostonBoston 3D®2024-04-30
00860010708125Boston BraceScoliosis: Boston Scoli-NightShiftBoston Night Shift 2024-04-30
00860010708132Boston BraceSoft Body JacketSoft Body Jacket2024-04-30
00860010708149Boston BraceScoliosis: Soft Body Jacket: Boston ScoliBoston Soft Spinal Orthosis (SSO)2024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05904569152253Aether Digital PlatformAETHER BIOMEDICAL SP Z O ONHF2023-10-31
05904569152260Aether Digital PlatformAETHER BIOMEDICAL SP Z O ONHF2023-10-31