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Boston Brace, Inc.

USA

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 8Class II 1Class III 0

plus 9 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 3 510(k), 0 PMA, 10 excluded

Brazil2 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: BOSTON BRACE INTERNATIONAL, INCORPORATED · Boston Brace, Inc.

Same-named companies — This database also contains companies with near-identical names: BOSTON BRACE INTERNATIONAL, INCORPORATED, Boston Brace Intl., Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12007 · K063098

12008 · K072862

12011 · K111609

FDA listed device types

showing 8 of 9

Orthosis, Limb Brace 1Joint, Knee, External Brace 1Orthosis, Lumbar 1Orthosis, Truncal/Orthosis, Limb 1Joint, Ankle, External Brace 1Medical Device Data System 1Orthosis, Thoracic 1Monitor, Orthotic/Prosthetic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K111609	BOSTON BAND	2011-08-22
US	K072862	BOSTON-BAND CRANIAL REMODLING ORTHOSIS	2008-01-22
US	K063098	STATIC CRANIOPLASTY ORTHOSIS	2007-04-11
BR	80889150003	Órtese de Remodelação Craniana CranialBand®	Class I
BR	80047300871	Dispositivos ortóticos para coluna vertebral e escoliose	Class I

Boston Brace, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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