FDA.reportPublic FDA data

Boston Brace

Primary DI
00860010708156
Brand
Boston Brace
Company
Boston Brace International, Inc.
Model
Scoliosis: Boston Scoli-Finish-Kyhosis -cowhorns
Catalog number
Boston Kyphosis Brace
Device description
Boston Kyphosis Brace
Published
2024-04-30
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
00860010708156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010708156008600107081568600107081560860010708156

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.262.2235customerservice@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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179882211CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882228CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882235CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882242CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882259CopperFitIdeavillage Products CorpIQE2026-10-01
00810179882402CopperFitIdeavillage Products CorpIQE2026-10-01
04068903520939MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520946MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520953MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520960MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
04068903520977MEDIMEDI MANUFACTURING, INC.IQE2026-08-21
06979144490449Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490456Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490463Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490470Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
06979144490487Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-20
00810178889648CoreTechVIVE HEALTH LLCIQE2026-08-19
06979144490241Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490258Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490265Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490272Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490289Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490296Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490302Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490319Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490326Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490333Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490340Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490357Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18
06979144490364Lumbar Support BraceJiangxi Weide Rehabilitation Health Management Co., LtdIQE2026-08-18