FDA.reportPublic FDA data

OPSB Sensor Cloud Backend

Primary DI
00860013109837
Brand
OPSB Sensor Cloud Backend
Company
Boston Brace International, Inc.
Model
SENSOR-CB-V1
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
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013109837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013109837008600131098378600131098370860013109837

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
00860013109806OPSB SensorSENSOR-V12025-02-21
00860013109813OPSB Sensor Mobile AppSENSOR-MA-V12025-02-21
00860013109820OPSB Sensor Web PortalSENSOR-WP-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
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28