Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008351005

FEI Number

3008351005

Entity Name

Care&Care Health Products Co., Ltd

City/State/Country

Yuanli Township Miaoli, TW

Establishment Address

No. 198, Daxing Rd., Yuanli Township Miaoli 358006, TW

Establishment Type(s)

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

Owner / Operator

Care&Care Health Products Co., Ltd (Owner Number: 10032051)

Owner / Operator Contact Address

No. 198, Daxing Rd.,, Yuanli Township, TW-MIA 358006, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Infusion Stand Hygiene Products Bedpan AC-Powered Patient Lift Wheelchair Armboard Wheelchair Anti-Tip Device Wheelchair Extension Brake Non-Measuring Exerciser Wheelchair Pusher Cuff Powered Exerciser Wheelchair Handrim Mechanical Table Crutch and Cane Holder Wheelchair Lap Board Wheelchair Accessories Holder Hill Wheelchair Non-Protective Restraint Caster with Chair Wheelchair Armrest Blood Pressure Measurement Wheelchair Cushion Wheelchair Components Mechanical Walker Scooter Prone Board Head and Trunk Support Cane Transfer Aid Wheelchair Adjustable Chair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2010-04-05
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2010-04-05
FOB	Bedpan	General Hospital	Class 1	880.6730	2017-11-22
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2012-05-09
IMY	Armboard, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-03
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2010-04-05
INC	Cuff, Pusher, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-03
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2022-03-31
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2010-04-05
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-03
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-03
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2012-03-10
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2012-09-03
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2012-09-03
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-02-12
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-03
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2012-03-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2016-09-28
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2012-09-03
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-03
IPS	Cane	Physical Medicine	Class 1	890.3075	2010-04-05
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2010-04-05
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2012-09-03

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

Care&Care Health 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

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-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008351005. Last updated year: 2026. Please use registration number 3008351005 when referencing this establishment in official correspondence.