FDA.reportPublic FDA data

Boston Band

Primary DI
00860010708101
Brand
Boston Band
Company
Boston Brace International, Inc.
Model
BB1
Device description
Boston Band custom cranial remolding orthosis
Published
2023-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111609000BOSTON BANDBoston Brace Intl., Inc.2011-08-22MVA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010708101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010708101008600107081018600107081010860010708101

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002622235customerservice@bostonoandp.com

Regulatory Flags#

DUNS number
801816158
Device count
1
Serial number
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
00859065006041Hanger Cranial BandSymbiont Logistics, LLCMVA2026-05-11
00860013898083TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860013898090Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00859065006034Sprout3DSurestep, LLCMVA2025-02-03
00859065006027Hanger Cranial Band 3DSymbiont Logistics, LLCMVA2024-12-26
B15176210A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176310A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176410A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176510A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
B15176610A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2024-10-17
00196852667895P-PODPPOD Orthotics Inc.MVA2023-11-20
B15170309A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170309PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170409PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909A0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170909PA0STARband® PlusORTHOMERICA PRODUCTS, INC.MVA2023-06-29
B15170910A0STARband® 3DORTHOMERICA PRODUCTS, INC.MVA2023-06-29