Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016170451

FEI Number

3016170451

Entity Name

Wenzhou Kangju Medical Instrument Co., Ltd.

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

81 Liuzhai Luodong South Street, Yongzhong, Wenzhou Zhejiang 325000, CN

Establishment Type(s)

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

Owner / Operator

Wenzhou Kangju Medical Instrument Co. Ltd (Owner Number: 10039342)

Owner / Operator Contact Address

81 Liuzhai Luodong South Street, Yongzhong, Wenzhou, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Adaptor, Hygiene Foot Spa Massager, Foot Massager, Neck and Shoulder Massager, Massage Cushion, Massage Hammer, Massage Pillow; Massage G Aneroid Sphygmomanometer, Blood Pressure Monitor Pinwheel Cane Scissors Wenzhou Kangju Blood Pressure Cuff Heating Pad WALKER, MECHANICAL Model OT-HWB,OT-RC Bottle hot/cold water PENLIGHT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-11-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-11-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2012-10-15
GWY	Pinwheel	Neurology	Class 1	882.1750	2011-12-29
IPS	Cane	Physical Medicine	Class 1	890.3075	2025-11-20
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-04-07
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-10-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-11-05
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2020-09-06
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2011-12-29
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2018-03-07

Official Correspondent

Shi Wen Li

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Wenzhou Kangju Medical Instrument 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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

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3019502344	FOSHAN MAIKANG MEDICAL EQUIPMENT CO., LTD	Foshan Guangdong, CN
3004126239	MERCHSOURCE LLC	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016170451. Last updated year: 2026. Please use registration number 3016170451 when referencing this establishment in official correspondence.