Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018109879

FEI Number

3018109879

Entity Name

Shenzhen Yicai Health Technology Co. , Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

11th floor, Zhenqian Building, Yousong Community, Longhua Street, Longhua District, Shenzhen Guangdong 518110, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen Yicai Health Technology Co. , Ltd (Owner Number: 10080936)

Owner / Operator Contact Address

11th floor, Zhenqian Building, Yousong Community, Longhua Street, Longhua District, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart Pill Organizers Medication Aids Pill Container Pill Holder Smart Pill Dispensers Pill Reminder Pill Case Medication Organizer K1013 K1023 K1065 K1008 K1061 K1060 K1011 K1006 K1063 K1012 K1065-L K1007 K1002 Eye Masks Sleep Eye Masks Steam Eye Masks Eye Massager Eye Mask with White Noise Eye Heat Massager Heated Eye Mask Bluetooth Eye Mask K6135 K6108 K6122 K6142 K6136 K6128 K6137 K6140 K6141 K6139 K6134-Easy Pulse Series K6138 K6117 K6171 K61C1 K6133 ice pack cold pack gel ice pack cold and hot pack K6147 K6107 K6106 K6123 K6156 K6145 K6134 K6144 K6146 K6105 K6155 K9036 K9039 elecrtic heat pad Electric Heating Pad Electric hot pad K9032 ice pack reusable heated pad heating wrap heat pad Heating pad Heater Pad cold hot pack reusable heated wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2022-01-06
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-09-21
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-01-06
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-08-25
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-08-25
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2021-07-02
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-08-04
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-08-04
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-03-08
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2021-03-08

Official Correspondent

Jie Xie

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Shenzhen Yicai 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
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-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018109879. Last updated year: 2026. Please use registration number 3018109879 when referencing this establishment in official correspondence.