Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010987649

FEI Number

3010987649

Entity Name

DYNAFOCUS INDUSTRY CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

2F., No. 101, Dingcheng 3rd St., Xindian Dist., New Taipei City 23106, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Dynafocus Industry Co., Ltd. (Owner Number: 10047044)

Owner / Operator Contact Address

2F., No. 101, Dingcheng 3rd St., Xindian Dist., New Taipei City, TW-NWT 23106, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cane, Safety Walk Mechanical walker & Rollator Crutch Aid, Transfer Daily activity assist device;adaptor, hygiene Mechanical Table Mechanical chair,with casters Wheelchair Component,Cushion Bedpan Infusion Stand Cane, crutch, and walker tips and pads Truncal Orthosis, Cervical Cast Protector Nonmeasuring Exercise Equipment Urinal Cane Noninvasive Traction Component

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2015-03-26
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-03-25
IPR	Crutch	Physical Medicine	Class 1	890.3150	2015-03-26
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-03-26
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-03-25
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2015-03-27
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-03-25
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2015-03-27
FOB	Bedpan	General Hospital	Class 1	880.6730	2015-03-26
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2015-03-27
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-03-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-03-27
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2014-06-17
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2015-03-26
FNP	Urinal	General Hospital	Class 1	880.6730	2015-03-27
IPS	Cane	Physical Medicine	Class 1	890.3075	2015-03-25
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2015-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Dynafocus Industry Co., Ltd.

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010987649. Last updated year: 2026. Please use registration number 3010987649 when referencing this establishment in official correspondence.