Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010785927

FEI Number

3010785927

Entity Name

HENGSHUI RUNDE MEDICAL INSTRUMENTS CO.,LTD

City/State/Country

Hengshui City Hebei, CN

Establishment Address

Sunyaocheng Village, Daziwen Town, Anping County, Hengshui City Hebei 053600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hengshui Runde Medical Instruments Co.,Ltd (Owner Number: 10053121)

Owner / Operator Contact Address

Sunyaocheng Village, Daziwen Town, Anping County, Hengshui City, CN-HE 053600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

commode chair Tourniquet Medical Splint, Bunion Splint Stretcher Bandage finger splint back massage Scissors Lumbar Support, Lumbar Orthosis, Back Posture Correction Belt, Magnetic Back Support Belt, Rescue Strap, Pelvic Sling Waist Trimmer Belt, Compression Wrap, Waist Support, Posture Correction Brace, Posture Corrector, Back Brace, Bath Chair Ankle Support, Ankle Night Splint; Ankle Brace First Aid Bag Chest Seal Cast Shoes, Walking Boot, Post-Op Shoe, Medical Shoe Cushion Gait Belt Arm Sling Over-Door Neck Traction Device, Air Neck Traction, Inflatable Neck Traction, Neck Collar, Hard Neck Collar Neck Brace; Neck Traction Frame, Neck Traction Chair; Memory Pillow ,Anti Snoring Chin Strap Neck Support, Neck Wrap, Neck Cushion, Cervical Collar, Cervical Traction, Philadelphia Neck Support hot cold pack Head Immobilizer Knee Pad, Neoprene Knee Support, Sport Knee Brace, Orthopedic Knee Brace Wooden Crutch; Elbow Brace; Knee Brace, Knee Support, Hinged Knee Brace Air Mattress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2018-12-22
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-11-02
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2016-11-02
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2016-11-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-11-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-12-22
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-12-22
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-08
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-11-02
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2025-01-03
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-11-02
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-01-22
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-01-22
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2016-11-02
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2018-12-22
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-01-03
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2016-11-02
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2016-11-02
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-12-22
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-01-22
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-11-02
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2016-11-02

Official Correspondent

Shuilian Shi

US Agent Details

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

Related Public Records

Same Entity

Hengshui Runde Medical Instruments 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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3012579728	FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO. LTD	Foshan City Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010785927. Last updated year: 2026. Please use registration number 3010785927 when referencing this establishment in official correspondence.