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OTTO BOCK JAPAN K.K.

Japan

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

49listed device types

Class I 44Class II 5Class III 0

plus 97 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

111registered devices

Class I 111

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

SASaudi ArabiaSFDA

53registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

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 States97 registration records, 30 510(k), 0 PMA

Brazil111 confirmed, 0 excluded

Saudi Arabia53 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH · OTTO BOCK HEALTHCARE CANADA · Otto Bock Healthcare Products GmbH · OTTO BOCK HEALTHCARE LP · OTTO BOCK HEALTHCARE PRODUCTS GMBH · OTTO BOCK MOBILITY SOLUTIONS GMBH

Same-named companies — This database also contains companies with near-identical names: OTTO BOCK ASIA PACIFIC LIMITED, OTTO BOCK (CHINA) INDUSTRIES CO., LTD., OTTO BOCK FRANCE SARL, OTTO BOCK HEALTH CARE. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11995

11999

52000

12003

42004

22005

12006

12007

22008

22009

12010

22011

12013

12014

12015

12019

12021

12022

12026

FDA listed device types

showing 8 of 49

Sling, Arm, Overhead Supported 1Orthosis, Lumbar 1Joint, Hip, External Limb Component 1Unit, Wrist, External Limb Component, Mechanical 1Hand, External Limb Component, Powered 1Splint, Hand, And Components 1Unit, Wrist, External Limb Component, Powered 1Crutch 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253256	myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)	2026-04-22
US	K213587	MyCRO Band	2022-06-09
US	K201426	MyCRO Band	2021-03-26
BR	10292010099	Cadeira de rodas Start Multi	Class I
BR	10292010072	Família de Cadeiras de Rodas Manuais Internacionais Ottobock	Class I
BR	10292010073	Família de Carrinhos de Transporte Terapêutico Ottobock	Class I
SA	ME0000021321SFDAA00001	AUTOMATIC RING LOCK KNEE JOINT	—
SA	ME0000006162SFDAA00001	MyoRotronic	—
CA	70376	MYOBOY SYSTEM	Class II
CA	82915	STIWELL MED4	Class II
CA	93853	MYGAIT STIMULATION SYSTEM	Class II

OTTO BOCK JAPAN K.K.

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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