Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614671

FEI Number

3005319488

Entity Name

NIPPON SIGMAX CO., LTD.

City/State/Country

SHINJUKU-KU Tokyo, JP

Establishment Address

1-24-1 Nishi-Shinjuku, 7th Floor, SHINJUKU-KU Tokyo 163-6033, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NIPPON SIGMAX CO., LTD. (Owner Number: 9032887)

Owner / Operator Contact Address

1-24-1 Nishi-Shinjuku, 7th Floor, Shinjuku-ku, JP-13 163-6033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zamst ZW-7 Zamst ZW-5 Zamst Filmista Wrist Zamst Thumb Guard Zamst Elbow Band Zamst Shoulder Wrap Zamst Wrist Band Zamst Filmista Ankle Zamst A2-DX Zamst A2-DX White Zamst A1 Zamst A1 White Zamst RK-1 Plus Zamst Filmista Knee Zamst JK Band Zamst EK-3 Zamst JK-2 Zamst EK-5 Zamst EK-1 Zamst JK-1 Zamst ZK-X Zamst ZK-7 ZK-Protect KNEE L ZK-Motion KNEE S ZK-Motion KNEE XL ZK-Protect KNEE XL ZK-Motion KNEE 3XL ZK-Protect KNEE 3XL ZK-Protect KNEE 2XL ZK-Motion KNEE 2XL ZK-Motion KNEE M ZK-Motion KNEE L ZK-Protect KNEE S ZK-Protect KNEE M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2008-04-21
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2008-04-21
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2007-12-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1998-02-04

Official Correspondent

Kennth Block

US Agent Details

Kenneth L Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

NIPPON SIGMAX CO., LTD.

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 9614671. Last updated year: 2026. Please use registration number 9614671 when referencing this establishment in official correspondence.