Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033849261

FEI Number

3033849261

Entity Name

HEBEI JUNLAOLE MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Hengshui City Hebei, CN

Establishment Address

1. South District 3-3-1, No. 888 Kaiyuan Road, Jizhou District, 2. North District 5-5 West, No. 999 Kaiyuan Road, Jizhou District, Hengshui City Hebei 053000, CN

Establishment Type(s)

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

Owner / Operator

Hebei Junlaole Medical technology Co.,ltd (Owner Number: 10091715)

Owner / Operator Contact Address

1. South District 3-3-1, No. 888 Kaiyuan Road, Jizhou District, 2. North District 5-5 West, No. 999 Kaiyuan Road, Jizhou District, Hengshui City, CN-HE 053000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Manual bed Stretcher Crutch, Walking stick Traction chair Traction bed Rail; Adaptor, Hygiene - Bath Bench; Commode Chair; Raised Toilet Seat; Shower Chair; ward screen Fitness Equipment Stretching Device Medical chair and table Electric hospital bed Medical stretcher, Medical Trolly; Stand, Infusion - I.V. Stand; Hospital furniture Crutch and cane, Wheelchair Bed accessories (Headboard, Footboard, Castors, Rail guard); Air cushion, Mattress, Air mattress Bed board

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2025-02-25
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2025-02-25
IPS	Cane	Physical Medicine	Class 1	890.3075	2024-10-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2026-05-27
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-10-27
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2026-05-27
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2026-05-27
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2025-02-25
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	2025-02-25
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-10-27
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2025-02-25
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2024-10-27
FPS	Board, Bed	General Hospital	Class 1	880.6070	2025-02-25

Official Correspondent

Cathy Huang

US Agent Details

Noah Zhang Business: HYPERCERT LIMITED Email: noah.zhang@hycerglobal.com Phone: (863) 3233636

Related Public Records

Same Entity

Hebei Junlaole Medical technology 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
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
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 3033849261. Last updated year: 2026. Please use registration number 3033849261 when referencing this establishment in official correspondence.