Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027645766

FEI Number

3027645766

Entity Name

BIONICM

City/State/Country

Hongo Bunkyo-ku Tokyo, JP

Establishment Address

The University of Tokyo Entrepreneur Plaza 203, 7-3-1, Hongo Bunkyo-ku Tokyo 1130033, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BionicM (Owner Number: 10088422)

Owner / Operator Contact Address

The University of Tokyo Entrepreneur Plaza 203, 7-3-1, Hongo Bunkyo-ku, JP-13 1130033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Asista

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2026-02-16

Official Correspondent

Susumu Tosaka

US Agent Details

Keiji Asada Business: Amenichi Consulting, LLC. Email: Keiji.Asada@Amenichi.com Phone: (312) 9332887

Related Public Records

Same Entity

BionicM

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027645766. Last updated year: 2026. Please use registration number 3027645766 when referencing this establishment in official correspondence.