Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012251300

FEI Number

3012251300

Entity Name

HANGZHOU ZHONGZHI INDUSTRY CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 608 Pacific Plaza, Dongning Road, Jianggan District, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou Zhongzhi Industry Co.,Ltd (Owner Number: 10055912)

Owner / Operator Contact Address

Room 608 Pacific Plaza, Dongning Road, Jianggan District, Hangzhou, CN-ZJ 310000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ankle sleeve, knee sleeve, elbow sleeve, arm sleeve, back brace compression stocking; Knee high compression stocking; Thigh high compression stocking; compression socks; calf sleeves; Diabetic socks Posture Cane And Cane Tip. CPAP Hose Holder Cup Holder. Balance Ball With Resistance Bands. Eye Masks Slipper Belt seat cushion Scarf Patella Strap. Waist support. Urinal Bottle, Urinary Drainage Bag, Specimen Collector, Kidney Stone Collector Resistance loop bands Sock Aid. Jump Rope. diabetic socks Wrist Support heel socks Compression Gloves. Compression Ankle Sleeve. Compression Wrist. Compression Garments. shoulder sleeve, full arm sleeve, full leg sleeve, Half Finger Gloves, arch support, Back brace Compression Socks. Compression Tank Top. Compression Pants. Foot Products. Straps. Compression T-Shirt. Compression Tights. Compression Elbow Sleeve. Compression Socks. Supports. Core Slider. GUARDIANGEL SOCKS(Diabetic compression socks), compression Shin Pad Sleeves. Metatarsal pad, bunion sleeve, compression thigh sleeve, powerknit thigh sleeve, posture corrector, compression head band. T-shirt, Hoodie, Sweatpants, Sweatshirt, legging, bra. knee sleeve, compression foot sleeve, powerknit elbow sleeve, powerknit knee sleeve, powerknit Compression Waist. Stockings. Sleeves. Compression Calf Sleeve. Compression Shorts. compression back support, compression shoulder brace, neck support, long sleeve glove, thumb support, Tennis Elbow Sleeve, Patella Sleeve, Wrist Band, Lifting Straps, Gloves. Orthotic Insoles Kinesiology Tape Stool. Yoga Exerciser Ball. Roller Wheel. Foam Roller. Pedestal Exerciser Bike. freeze foot wrap, freeze calf sleeve, freeze heavy vest, Freeze finger sleeve, freeze toe sleeve, freeze posture corrector, freeze thumb sleeve Freeze Back Wrap, Freeze Shoulder Wrap, Freeze Leg Sleeve. Freeze half finger glove, freeze full finger glove, freeze neck wrap, freeze head wrap, freeze elbow sleeve, Freeze Knee Sleeve, Freeze Ankle Sleeve, Freeze Wrist Sleeve, Freeze Eyemask, Memory And Spa Pillow.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2024-09-14
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2025-07-22
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2020-12-19
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-12-19
IOE	Bars, Parallel, Exercise	Physical Medicine	Class 1	890.5370	2020-12-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2019-06-06
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-12-19
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2019-06-06
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2022-01-18
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2019-06-26
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-10-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-06-06
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-12-19
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2020-12-19
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2020-12-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-06-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-12-19

Official Correspondent

Jing Li

US Agent Details

Jame Chen Email: ssgxcfe@outlook.com Phone: (805) 3513025

Related Public Records

Same Entity

Hangzhou Zhongzhi Industry 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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3015199390	RUNWAY KNITTING INC	Rainsville, AL, US
2320779	BARTON-CAREY MEDICAL PRODUCTS, INC.	JELLICO, TN, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012251300. Last updated year: 2026. Please use registration number 3012251300 when referencing this establishment in official correspondence.