Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016426850

FEI Number

3016426850

Entity Name

COFOE MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COFOE MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10061943)

Owner / Operator Contact Address

No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230277

PMA Number

N/A

All Registered Proprietary Names

Back support strap Back Brace Posture Corrector Walker Ostomy tie strip Skin Barrier Wipe Ostomy Belt Cane Adult Diapers (Garment, Protective, For Incontinence) Pull up pants Medical Nursing Pads CERVICAL FIXATOR Neck Brace Knee Strap Knee Brace Wrist Brace Ankle Brace Elbow Brace Infrared Thermometer TDP lamp lumbar fixation belt lumbar support Lumbar Support belt Anti-decubitus Mattress Air Mattress with Compressor Air Mattress Mattress Alternating Pressure Pump & Bubble Mattress Adhesive Remover Adhesive stripper rub oxygen regulator Suction machine(stationary aspirator) Pulse Oximeter(Model OHT 60XH78)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2024-06-17
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2021-05-10
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-11-25
IPR	Crutch	Physical Medicine	Class 1	890.3150	2021-05-10
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2021-11-19
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-07-25
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-07-02
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-02-12
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-03-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2024-06-17
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2024-11-15
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2024-11-25
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2022-07-28
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2022-07-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-01-09

Official Correspondent

Xueqin Huang

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

COFOE 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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

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-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number	Establishment Name	Location
3010884328	SCOLICARE	Kogarah New South Wales, AU
3009562727	Eckart KLOBE	Mannheim Baden-Wurttemberg, DE
3012453117	TREND MEDICAL, LLC	Bethlehem, PA, US
1226318	SPINAL TECHNOLOGY, LLC	West Yarmouth, MA, US
3010694026	BREG, INC.	Indianapolis, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016426850. Last updated year: 2026. Please use registration number 3016426850 when referencing this establishment in official correspondence.