FDA.reportPublic FDA data

Boston Brace

Primary DI
00860010708170
Brand
Boston Brace
Company
Boston Brace International, Inc.
Model
Boston Brace RC
Catalog number
Boston RC
Device description
Boston RC
Published
2024-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPTOrthosis, Thoracic
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010708170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010708170008600107081708600107081700860010708170

GMDN Terms#

Term, Definition table
TermDefinition
Multiple spinal region orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.262.2235customerservices@bostonoandp.com

Regulatory Flags#

DUNS number
801816158
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
00860013109837OPSB Sensor Cloud BackendSENSOR-CB-V12025-02-21
00860010708163Boston BraceBoston Brace Original Boston Original 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
00843776106367Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776106374Neotech CareNEOTECH CARE INC.IQE2026-07-17
00843776100013Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100020Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100037Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100044Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100051Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100099Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102499Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102505Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102512Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102529Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102536Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103007Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103014Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103021Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103038Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103045Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105957Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105964Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105971Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105988Neotech CareNEOTECH CARE INC.IQE2026-07-14
00810178888092CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888665CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888894CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889075CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889174CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889259CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889266CoreTechVIVE HEALTH LLCIPT2026-05-05
00850071315264TrendOrthofix US LLCIPT2026-04-25