Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023326918

FEI Number

3023326918

Entity Name

HUIZHOU XINYI TECHNOLOGY CO., LTD

City/State/Country

Huizhou Guangdong, CN

Establishment Address

(Building 3), Changbu Village, Xinwei, Huiyang District, Huizhou Guangdong 516200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huizhou XINYI Technology Co., LTD (Owner Number: 10087052)

Owner / Operator Contact Address

(Building 3), Changbu Village, Xinwei, Huiyang District, Huizhou, CN-GD 516200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Red light pillow Z08-9 Red light knee therapy device Z08-4 Red light hand therapy device Z08-1 Red light waist therapy device Z08-3 Red light foot therapy device Z08-6 Red light leg therapy device YY-A39 Red light mat Z08-2;Z09-M1;Z09-M2 HOMEDICS OPP KNEE+FOOT+CONTROLLER:SR-CMXKF10HJ AIR COMPRESSION LEG MASSAGER:YY-A28,YY-A29,YY-A30 HOMEDICS DYNAMIC FULL LEG AIR COMPRESSION MASSAGER:SR-170J,SR-170SMJ,SR-170LXJ AIR COMPRESSION LEG MASSAGER:YY-A01L,YY-A01,YY-A14L Portable Sequential Compression System Coretech:RHB3040 YY-A14L Air compression leg massager HOMEDICS OPP KNEE+FOOT+CONTROLLER:SR-CMXKF5SHJ HoMedics OPP Knee+Controller SR-CMXK5SHJ,SR-CMXK5SHJ-BK MEDISANA AIR COMPRESSION LEG MASSAGER:LM900/LM950 HoMedics Modulair Knee+Controller SR-CMXK10HJ HoMedics Modulair Knee wrap SR-CMK10HJ YY-A01L Air compression leg massager HoMedics OPP Knee wrap SR-CMK5SHJ,SR-CMK5SHJ-BK Air Relax 5 AR-5 Red light waist therapy device Z08-3 Red light knee therapy device Z08-4 Red light foot therapy device Z08-6 Red light hand therapy device Z08-1 Red light leg therapy device YY-A39 Red light pillow Z08-9 Red light mat Z08-2;Z09-M1;Z09-M2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-06-05
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-08-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-06-05

Official Correspondent

Anna Chow

US Agent Details

Anna SUN Business: Anna Sun Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Huizhou XINYI 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
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023326918. Last updated year: 2026. Please use registration number 3023326918 when referencing this establishment in official correspondence.