Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011786430

FEI Number

3011786430

Entity Name

SHIJIAZHUANG RUNYI MEDICAL DEVICE TECHNOLOGY CO.,LTD.

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

No. 2602, Unit 2, Zhongheng Business Office Building, No. 28, Jianhua North Street, Chang'an District, Shijiazhuang Hebei 050000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shijiazhuang RUNYI Medical Device Technology Co.,Ltd. (Owner Number: 10049499)

Owner / Operator Contact Address

No. 2602, Unit 2, Zhongheng Business Office Building, No. 28, Jianhua North Street, Chang'an District, Shijiazhuang, CN-HE 050000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back Brace & Support,Pelvis Support Belt Face Mask Neck Traction/Pillow Hand Support/Splint, Neck brace & Support, Shoulder Brace & Support Knee Support, Hinged Knee Brace, Beactive Knee Brace cushion Arm Sling Postpartum/Abdominal Binder Calf Support,Thigh Support Night splint,splint mask Mattress Maternity Support posture support Ankle Brace & Support,Walker Brace/Boot,foot insole

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2015-06-08
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-06-08
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2015-06-08
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-06-08
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2015-06-08
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2015-06-08
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2015-06-08
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2015-06-08
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2015-06-08
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2018-12-18
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2015-06-08
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2015-06-08
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2018-12-18
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-06-08

Official Correspondent

Damita Zhang

US Agent Details

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

Related Public Records

Same Entity

Shijiazhuang RUNYI Medical Device Technology 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011786430. Last updated year: 2026. Please use registration number 3011786430 when referencing this establishment in official correspondence.