ZHONGSHAN CHUKUANG TEXTILE CO., LTD.

FDA Device Registration & Listing · Zhongshan City, Guangdong, CN · Registration 3013374101

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013374101
FEI Number
3013374101
Entity Name
ZHONGSHAN CHUKUANG TEXTILE CO., LTD.
City/State/Country
Zhongshan City, Guangdong, CN
Establishment Address
Baishawan Second Industrial Area,, East District,, Zhongshan City, Guangdong 528403, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
ZHONGSHAN CHUKUANG TEXTILE CO., LTD. (Owner Number: 10052917)
Owner / Operator Contact Address
Baishawan Second Industrial Area,, East District,, Zhongshan City,, CN-GD 528403, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Grounding Blanket, Grounding Mat for Feet, Grounding Socks, Fitted Ground Sheet Gounding sheet, Grounding mat, Grounding Earthing Sheet, Grounding Wrist Strap, Grounding Wire, Grounding Pillowcase, Orthosis, foot drop Neck Hammock Red Light Therapy for Shoulder, Red Light Therapy Device for Body Calf Arm, Red Light Therapy waistcoat, Red Light Therapy sleeping bag, Red light therapy hat, Red light therapy mask, Red light therapy knee, Red-Light-Therapy-for-Face and Neck, Red light therapy shawl, Red Light Therapy, Near Infrared Light Therapy Device, Red Light Therapy Wrap, Red Light Therapy Mat, Red Light Therapy Lamp, Red Light Therapy Belt, Red Light Therapy Panel Red light therapy for arm, Red light therapy boots, Red Light Therapy for Feet, Red Light Therapy for Body, JOINT, HIP, EXTERNAL BRACE SUPPORT, ARM Band or Belt, Pelvic Support, Castor Oil Pack Disposable protective coverall cloths Disposable face mask Gloves Face Shield Goggle ORTHOSIS, LUMBAR Joint, Knee, External Brace, Sports Gloves Orthosis, Truncal/Orthosis, Limb posture corrector Orthosis, Abdominal anti snoring chin belt Bandage, Elastic Cage, Knee Disposable face mask Sling, Arm 3D ankle fracture stabilizer, Ankle Splint Joint, Ankle, External Brace, ankle support, ankle brace, sprained ankle Stabilizer, Rapid-Setting Splint ankle brace, Instant Cold Pack SPLINT, HAND, AND COMPONENTS Baby Head Protector(anti-fall pillow,safety helmet) ORTHOSIS, LIMB BRACE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IOD Components, Exercise Physical Medicine Class 1 890.5350 2025-03-16
OHI Orthosis, Foot Drop Physical Medicine Class 1 890.3475 2016-10-18
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2019-12-29
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2024-01-08
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2016-10-18
IOY Support, Arm Physical Medicine Class 1 890.3475 2016-10-18
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2016-10-18
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-11
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-03-11
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2020-04-09
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2020-04-09
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2016-10-18
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2016-10-18
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2016-10-25
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2016-10-25
LWF Dilator, Nasal Ear, Nose, Throat Class 1 874.3900 2017-12-17
FQM Bandage, Elastic General Hospital Class 1 880.5075 2016-10-18
ITM Cage, Knee Physical Medicine Class 1 890.3475 2016-10-25
QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Unknown Class N N/A 2020-04-09
ILI Sling, Arm Physical Medicine Class 1 890.3640 2016-10-18
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2016-10-18
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2024-03-17
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2016-10-18
IRS Head Halter, Traction Physical Medicine Class 1 890.5925 2019-12-29
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2016-10-18

Official Correspondent

JIANQUN LIN

US Agent Details

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

Related Public Records

Same Entity

ZHONGSHAN CHUKUANG TEXTILE 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
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-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013374101. Last updated year: 2026. Please use registration number 3013374101 when referencing this establishment in official correspondence.
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