Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038636181

FEI Number

3038636181

Entity Name

DONG GUAN YUNZHISHANG HEALTH TECHNOLOGY CO.,LTD.

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

No. 47, Luxi 2nd Road, Liaobu Town, Dongguan City Guangdong 523400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dong Guan Yunzhishang Health Technology Co.,ltd. (Owner Number: 10093564)

Owner / Operator Contact Address

No. 47, Luxi 2nd Road, Liaobu Town, Dongguan City, CN-GD 523400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heating Massage Knee; Heating Knee Joint Knee External Brace; Sports Gloves; Arm External Brace; Shoulder Support Hot and Cold; Heating Shoulder Support; Grounding Mat for Bed; Grounding Wire; Grounding Fitted Sheet; Grounding Pad; Grounding Pillowcase; Grounding Blanket; Grounding Sheets; Grounding Earthing Sheet; Grounding Mat for Improved Sleep; Grounding Mat; Grounding Wrist Strap; Grounding Strap; Grounding Mat for Feet; Grounding Socks Anti Snoring Chin Belt Assembly Shoulder/Elbow/Forearm/Wrist/Hand Mechanical Plantar Fasciitis Night Splint; Carpal Tunnel Night Splint; Orthosis Limb Brace; Splint Hand Band Or Belt, Pelvic Support; Castor Oil Pack; Heating Castor Oil Packs Apparatus Traction Non-Powered; Neck Hammock; Head Halter Traction Food Warming Mat; Warming Mat for Food; Heated Jacket; Heated Vest; Heated Blanket; Heated Pad; Heating Gloves; Heating Knee Heated Socks; Heating Shoulder Support; Heated Ankle Support Brace; Heated Ankle Support Brace; Heating Massage Knee; Heating Massage Knee Joint Ankle External Brace; Orthosis Foot Drop; Heated Ankle Support Brace Drop Foot Brace; Ankle Foot Brace; Drop Foot Splint;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-06-04
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2025-06-04
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-06-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-06-05
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-06-05
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2025-06-05
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2025-06-05
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-06-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-06-05
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-06-05

Official Correspondent

An Shu Zhang

US Agent Details

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

Related Public Records

Same Entity

Dong Guan Yunzhishang Health 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038636181. Last updated year: 2026. Please use registration number 3038636181 when referencing this establishment in official correspondence.