Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615543

FEI Number

3004839326

Entity Name

MAXHEALTH CORP.

City/State/Country

Xizhi District, New Taipei City, TW

Establishment Address

14F, No. 99, Section 1, Xintai 5th Road, Xizhi District, New Taipei City 22102, TW

Establishment Type(s)

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

Owner / Operator

MAXHEALTH CORP. (Owner Number: 9012436)

Owner / Operator Contact Address

14F, No. 99, Section 1, Xintai 5th Road, Xizhi District, New Taipei City, TW-TPE 22102, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cane Walker & Rollator PVC Decubitus Ulcer Cushion Mechanical Wheelchair chair and table Head Strap Chair, with casters Exercise Pulley Set Shower Bench & Chair Crutches Commode Tips and Pads, Cane, Crutch and walker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPS	Cane	Physical Medicine	Class 1	890.3075	1998-07-20
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2007-04-25
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2020-02-20
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2000-06-14
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2006-06-23
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2017-03-17
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2003-10-06
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2008-12-25
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2012-03-19
IPR	Crutch	Physical Medicine	Class 1	890.3150	2006-03-23
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2006-05-09
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2006-03-23

Official Correspondent

DICKSON SU

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

MAXHEALTH CORP.

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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
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

Similar Registrations

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3034731542	GUANCHI TECHNOLOGY (HEBEI) CO., LTD.	Hengshui Hebei, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615543. Last updated year: 2026. Please use registration number 9615543 when referencing this establishment in official correspondence.