Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009282549

FEI Number

3009282549

Entity Name

DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Liwu Shiwan Boluo Guangdong, CN

Establishment Address

Second Street Yongshi Blvd, Shiwan Boluo guangdong, Liwu Shiwan Boluo Guangdong None, CN

Establishment Type(s)

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

Owner / Operator

DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD. (Owner Number: 10038725)

Owner / Operator Contact Address

Second Street Yongshi Blvd, Shiwan Boluo guangdong, Liwu Shiwan Boluo, CN-GD None, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K915262

PMA Number

N/A

All Registered Proprietary Names

Non-surgical isolation gown Bed rail Manual bed Face Shield Disposable Medical Mask Ice Bag Walker Rollator IV Pole Resting Hand Splint, Brace Surgical Cap Pedal Exerciser MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare Showerbuddy LLC ALEX ORTHOPEDIC, INC. PCP CHAMPION Replacement Foam Grip, Black Wooden Bed and Lap Tray Over bed table Commode Toilet seat Extendable Back Scratcher,Blue Extendable Back Scratcher,Black Extendable Back Scratcher,Pink Bath bench Rubber Bath Mat Small 70cm X 40cm White Grab bar Bath rail Crutch Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-06
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2011-11-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-04-17
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2011-11-07
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2011-11-07
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-04-02
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-06
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2014-11-19
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2016-02-22
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2011-11-07
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2011-11-07
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2011-11-07
IPR	Crutch	Physical Medicine	Class 1	890.3150	2011-11-07
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2011-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043749706	DOUBLE CARE MEDICAL TECHNOLOGY CO.,LTD.	Huizhou City Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009282549. Last updated year: 2026. Please use registration number 3009282549 when referencing this establishment in official correspondence.