FDA.reportPublic FDA data

Lower Limb Orthotics

Primary DI
00860013109882
Brand
Lower Limb Orthotics
Company
Boston Brace International, Inc.
Model
Hip Knee Ankle Foot Orthosis (HKAFO)
Catalog number
Hip Knee Ankle Foot Orthosis (HKAFO)
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013109882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013109882008600131098828600131098820860013109882

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-joint lower limb orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the lower body which will include the knee (e.g., hip and knee, knee and ankle). The device is typically adjustable and articulating. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801816158
Device count
1
Premarket exempt
true
Lot or batch
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
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
00860010708149Boston BraceScoliosis: Soft Body Jacket: Boston ScoliBoston Soft Spinal Orthosis (SSO)2024-04-30

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