Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004425765

FEI Number

3004425765

Entity Name

SHENZHEN GIFTSHINE TECHNOLOGY CO LTD

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

2/F, Block A4, Xinfu Industrial Park, Zhancheng Community, Fuhai Street, Baoan District, SHENZHEN Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHENZHEN GIFTSHINE TECHNOLOGY CO LTD (Owner Number: 9061916)

Owner / Operator Contact Address

2/F, Block A4, Xinfu Industrial Park, Zhancheng Community, Fuhai Street, Baoan District,, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Econo Alarm Personal Alarm Alarm Belt Chair, Bed & Floor Pad Alarm Sensor Pad Padded Hand Mitt Ultra Soft Boot Geri Sleeve Arm Super Soft Heel Protector Geri Sleeve Leg Hip Ease Heel Float Drainage Bag Cath Leg Strap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2004-03-11
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2019-08-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2011-07-16
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-07-16

Official Correspondent

JAMES WANG

US Agent Details

John DeVito Business: SKIL-CARE CORP. Email: jdevito@skil-care.com Phone: (914) 9632040

Related Public Records

Same Entity

SHENZHEN GIFTSHINE 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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Similar Registrations

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3042285590	SHENZHEN SHENGZHOU INTELLIGENT EQUIPMENT R&D CO., LTD.	Shenzhen Guangdong, CN
3017607477	ZHONGSHAN SAXIN ELECTRIC HEATING TECHNOLOGY CO., LTD.	Zhongshan Guangdong, CN
3043139378	FASTSOUND ACOUSTIC TECHNOLOGY (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004425765. Last updated year: 2026. Please use registration number 3004425765 when referencing this establishment in official correspondence.