Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014209670

FEI Number

3014209670

Entity Name

CYBERDYNE INC.

City/State/Country

Tsukuba Ibaraki, JP

Establishment Address

2-2-1 Gakuen-minami, Tsukuba Ibaraki 305-0818, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

CYBERDYNE Inc. (Owner Number: 10056809)

Owner / Operator Contact Address

2-2-1 Gakuen-minami, Tsukuba, JP-08 305-0818, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233695

PMA Number

N/A

All Registered Proprietary Names

Medical HAL Single Joint Type Medical HAL Lumbar Type HAL for Medical Use Lower Limb Type Medical HAL Single Joint Type Medical HAL Lumbar Type Medical HAL Lower Limb Type

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2021-08-04
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2025-12-03
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2020-11-13
PHL	Powered Exoskeleton	Physical Medicine	Class 2	890.3480	2020-11-13
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2021-08-04
PHL	Powered Exoskeleton	Physical Medicine	Class 2	890.3480	2024-12-02
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2024-12-02

Official Correspondent

Yohei Suzuki

US Agent Details

Hiroki Kimura Business: CYBERDYNE USA INC. Email: kimura_hiroki@cyberdyne.jp Phone: (888) 5896216

Related Public Records

Same Entity

CYBERDYNE Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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3042953497	ASPEN BUSINESS SOLUTIONS LLC	North Ogden, UT, US
3007123908	APOTHECARIES SUNDRIES MFG PVT LTD	GURUGRAM Haryana, IN
3011816892	TURBOMED ORTHOTICS INC.	St-Augustin Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014209670. Last updated year: 2026. Please use registration number 3014209670 when referencing this establishment in official correspondence.