Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005555653

FEI Number

3005555653

Entity Name

CAREMAX REHABILITATION EQUIPMENT CO., LTD.

City/State/Country

Foshan City Guangdong, CN

Establishment Address

Pingnan Industrial Area, Shugang Dadao, Pingzhou Town, Nanhai Area, Foshan City Guangdong 528251, CN

Establishment Type(s)

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

Owner / Operator

CAREMAX REHABILITATION EQUIPMENT CO., LTD. (Owner Number: 9082081)

Owner / Operator Contact Address

Pingnan Industrial Area, Shugang Dadao, Pingzhou Town, Nanhai Area, Foshan City, CN-GD 528251, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV Pole Bath Bench Toilet Seat Commode F-001D F-019D Fb-012E #XL F-018A F-017C WM-0203HA F-001C Fb-4312A F-017 FB-012 F-003 F-016 F-005B #XLWM-KS FB-012A F-001E Fb-012H #S WM-0203HB WM-KS#S Fb-012H # M WM-0203HC SH-0212 SH-0214 AF-005A F-001B Fb-012E #S F-019 FB-012B F-001A Fb-012E #L WM-KS#L F-009 FB-011A EX-2 WA-0203HA F-002B WM-KS#M F-004 F-019A F-002 F-016B F-016A F-006 FB-012D Fb-4312B SH-0213L WM-KS#XL F-016C WA-0203HC Fb-2518 F-008 EX-1 F-010 Walker Rollator Grab Bar Bath Rail Pedal Exerciser CPR Mask Cane Over Bed Table Crutch Manual Bed Bed Rail Transport Chair Stocking Socks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2006-01-23
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2006-01-23
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2020-05-08
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2006-01-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2006-01-23
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2014-11-19
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2014-11-12
IPS	Cane	Physical Medicine	Class 1	890.3075	2006-01-23
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2006-01-23
IPR	Crutch	Physical Medicine	Class 1	890.3150	2006-01-23
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2007-08-28
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2006-01-23
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2021-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

CAREMAX REHABILITATION EQUIPMENT 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005555653. Last updated year: 2026. Please use registration number 3005555653 when referencing this establishment in official correspondence.