Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003772414

FEI Number

3003772414

Entity Name

TOP LONGMAX PRODUCTS CO., LTD.

City/State/Country

TAICHUNG, TW

Establishment Address

28, SHIH CHENG S. 1ST., RD, TAICHUNG 407, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TOP LONGMAX PRODUCTS CO., LTD. (Owner Number: 9027105)

Owner / Operator Contact Address

28, SHIH CHENG S. 1ST., ROAD, --, TAICHUNG, TW-NOTA 407, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMMODE Baum Carbon-Fiber-Insole Shoebaum Ergo Brace MA-HR-AB-CBT MA-HR-AB-CBT Ergo Pad MA-HR-AB-CBT MA-HR-AB-CBT Ergo Brace MA-SB-1.5-SP-PAD-A Shoebaum Ergo Cap ErgoBaum COMMODE Baum Heater Baum

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-12-29
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2007-07-02
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2023-06-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2007-07-02
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2014-12-11
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2017-11-27
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2014-12-11
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2007-07-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2007-07-02
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2013-01-28
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2007-07-02
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2013-01-28
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2014-12-11
NXE	Walker, Mechanical, Poly Vinyl Chloride (Pvc)	Physical Medicine	Class 1	890.3825	2007-07-02
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2007-07-02
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Bernardo Birnbaum Business: Ergoactives, LLC Email: birnbaumb@gmail.com Phone: (305) 3595031

Related Public Records

Same Entity

TOP LONGMAX PRODUCTS 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003772414. Last updated year: 2026. Please use registration number 3003772414 when referencing this establishment in official correspondence.