Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030539818

FEI Number

3030539818

Entity Name

NINGBO UNICO PRODUCTS CO., LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Floor.3th, Building 5, No.5 Hongda Rd, Jiangbei, Ningbo Zhejiang 315033, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ningbo Unico Products Co., Ltd (Owner Number: 10089925)

Owner / Operator Contact Address

Floor.3th, Building 5, No.5 Hongda Rd, Jiangbei, Ningbo, CN-ZJ 315033, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FINGER SPLINT, ARTHRITIS GLOVES, carpal tunnel night brace, wrist night brace, wrist brace CANE, FOLDING SEAT CANE WRIST BRACE, BUNION PADS PILL ORGANISER, PILL CUTTER FINGER COTS, FINGER STALLS RING CUSHION, CUSHION, GEL CUSHION, MEMORY FOAM CUSHION REACHER, Plate Guard, Dinner plates and bowls, Cup and mug, Bath brush, Utensil holder, Easy grip utensils, Eye Drop Aid, Hand exercise ball, Therapy ball, Anti slip matTelescope mirror DISPOSABLE UNDERPADS WOOD TRANSFER BOARDS URINAL BACK SUPPORT ARM SLING SHOWER STOOL, RAISED TOILET SEAT HOT COLD PACK CAST PROTECTOR Roeder Manipulation test, O'Connor Dexterity Test, PIN, Hand Tool Dexterity Test, Manipulation and Dexterity Test ELASTIC BANDAGE, TUBULAR BANDAGE NECK COLLAR EAR SYRINGE Heating Pad, Heating pad wrap shoulder and neck EYE PATCH SITZ BATH DROPPER, ORAL SYRINGE Body fat monitor SPORT SUPPORT ICE BAG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-01-23
IPS	Cane	Physical Medicine	Class 1	890.3075	2024-01-23
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-01-23
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2024-01-23
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-01-23
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2024-01-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-06-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-01-23
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-01-23
FNP	Urinal	General Hospital	Class 1	880.6730	2024-01-23
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2024-01-23
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-01-23
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-01-23
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-01-23
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2025-06-11
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2026-05-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-01-23
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2024-01-23
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2024-01-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-09-10
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-01-23
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2024-01-23
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2024-01-23
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2026-01-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-01-23
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-01-23

Official Correspondent

Wenjun Wang

US Agent Details

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

Related Public Records

Same Entity

Ningbo Unico Products 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

Registration Number	Establishment Name	Location
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3014125510	JIANGMEN HENG MEI GLOVES & DECORATION CO. LTD.	JIANGMEN Guangdong, CN
3023344913	AR ORTHOPEDICS, LLC	Newberry, FL, US
3041725026	Fill Mill	Lakewood, NJ, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030539818. Last updated year: 2026. Please use registration number 3030539818 when referencing this establishment in official correspondence.