Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611742

FEI Number

3003117095

Entity Name

OTTO BOCK (CHINA) INDUSTRIES CO., LTD.

City/State/Country

BEIJING, CN

Establishment Address

NO. 3 GUANGYUAN DONG JIE, TONGZHOU INDUSTRY DEVELOPMENT AREA, BEIJING 101113, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ottobock SE & Co. KGaA (Owner Number: 8010097)

Owner / Operator Contact Address

Max-Naeder-Strasse 15, Duderstadt, DE-NI 37115, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FitKit WalkOn Lateral Junior FitKit WalkOn Lateral Heel wedges 10 degrees, 16 degrees, 22 degrees X-ible flexible ankle joints WalkOn Fit Kit Mulfifunction correction system joints WalkOn Flex Fit Kit Dual Function Ankle Joint Nexgear extension bars Multifunctional system ankle joint Infinity Air Walker, high System-toe Pick-up Ank.Jt. Malleo TriStep Ankle Orthosis Ankle Support Active Contour Ankle Joint Dyna Ankle - Dynamic Ankle Orthosis Concealed Spring Ankle Joint WalkOn Trimable Infinity Air Walker, low Malleo Neurexa System-Limit Mot Ankle Jt. WalkOn Reaction Malleo Sprint WalkOn Reaction Fit Kit WalkOn Reaction Plus Fit Kit Carbon Ankle Seven System Ankle Joint With Lam. Set Walk On Flex Malleo Immobil Night Splint FitKit WalkOn Reaction Lateral FitKit WalkOn Flex Junior Nexgear Tango Ankle Joint Nexgear side bar bilateral GoOn Achillo Sensa WalkOn Reaction Plus, Junior Malleo Sensa Heel wedges 15 degrees, 30 degrees Malleo Direxa Stirrup Unilateral Ankle Joint Walk-On AFO Medial joint for correction joint Reaction modul Foot stirrup WalkOn lateral Nexgear lamination bar bilateral WalkOn Reaction lateral Malleo Neurexa pro Heel Relief Orthosis Des. By Dr. Settner Dorso Osteo Care Spinal Orthosis Lumbo Direxa Stable Lumbo Sensa, women Spine Sport Dosi EQ X Multi 627, 631, 637 Lumbo Sensa Lumbo Direxa Woman Dorso Direxa Posture Dorso Carezza Posture Lumbo Carezza Lumbo Direxa High Dyneva Dorso Direxa Basic Dyneva light Hyperextension orthosis Hyperextension brace Lumbo Tristep Lumbo Direxa Wristoform wrist support Hallux Valgus ComfortT Manu 3D Correction adapter set C-Brace Trial Orthosis Foot Plates ORTHOVALLEY AFO Solid Ankle Ankle Joint -Stainl.Steel- Manu 3D Basis Stainless Steel Elbow Joint Bars Acro ComforT Shoulder Support Epi Forsa Plus Epi Sensa Ankle Foot Orthosis ORTHOVALLEY AFO Night Splint ORTHOVALLEY AFO articulated Malleo Immobil Air Walker, low Hallux Valgus Combo ComfortT Manu Comfort Ankle Joint for Children Manu 3D Pollex Stainless Steel Elbow Joint Bar with Gable Lock Manu Comfort Stable Double Act. Ankle Jt. Child Epiflex Stainless Steel Elbow Joint Bar without Lock ORTHOVALLEY Supramalleolar Orthosis Syst. Positioning Joint Thumboform Long Malleo Immobil Air Walker, high Omo Neurexa Plus Various models CPM pad kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-07-28
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2005-07-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2005-09-26
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2003-12-11
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2013-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

Caleb Beck Business: Otto Bock HealthCare LP Email: Caleb.Beck@ottobock.com Phone: (801) 9746647

Related Public Records

Same Entity

Ottobock SE & Co. KGaA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007923118	Otto Bock Mobility Solutions GmbH	Koenigsee Thuringia, DE
9681725	Otto Bock Manufacturing Konigsee GmbH	Koenigsee Thuringia, DE
3001917653	OTTO BOCK ITALIA SRL	BUDRIO Bologna, IT
3018070833	Ottobock Manufacturing Bulgaria EOOD	Blagoevgrad, BG
3005190268	Otto Bock Healthcare Products GmbH	Vienna Wien, AT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611742. Last updated year: 2026. Please use registration number 9611742 when referencing this establishment in official correspondence.