Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012464408

FEI Number

3012464408

Entity Name

HEBEI YOUJIE MEDICAL DEVICES CO., LTD

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

Room 1210, Tower B, Haiyue Tiandi, No. 66 West Yuhua Road, Qiaoxi District, Shijiazhuang Hebei 050051, CN

Establishment Type(s)

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

Owner / Operator

HEBEI YOUJIE MEDICAL DEVICES CO., LTD (Owner Number: 10051650)

Owner / Operator Contact Address

Room 1210, Tower B, Haiyue Tiandi, No. 66 West Yuhua Road, Qiaoxi District, Shijiazhuang, CN-HE 050051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neck Traction Wheelchair Abdominal Binder Air Cushion Waist Support Belt; Maternity Support Belt; Pelvic Support Belt Finger Splint Knee Brace; Elbow Brace Ice bag Crutch Posture corrector; Back brace Arm sling Mask Knee Massager; Leg Massager; Waist Massager; Neck Massager; Feet Massager Ankle Brace Nasal irrigator Anti Decubitus Mattress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-04-16
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2020-01-08
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2026-02-02
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2016-04-16
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2016-04-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-06-12
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-04-16
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2023-12-14
IPR	Crutch	Physical Medicine	Class 1	890.3150	2020-01-08
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2023-12-14
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2020-01-08
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-03-31
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-02-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-04-16
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2023-12-14
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2016-04-16

Official Correspondent

Meng Li

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HEBEI YOUJIE MEDICAL DEVICES CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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 3012464408. Last updated year: 2026. Please use registration number 3012464408 when referencing this establishment in official correspondence.