Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021594370

FEI Number

3021594370

Entity Name

TAIZHOU YUNKAI TECH CO LTD

City/State/Country

TAIZHOU Zhejiang, CN

Establishment Address

5 Hengxing Road,Beiyang Town,Huangyan District, TAIZHOU Zhejiang 318020, CN

Establishment Type(s)

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

Owner / Operator

TAIZHOU YUNKAI TECH CO LTD (Owner Number: 10083787)

Owner / Operator Contact Address

5 Hengxing Road,Beiyang Town,Huangyan District, TAIZHOU, CN-ZJ 318020, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AUDODO Read Light Therapy Lamp: YM013 AUDODO Red Light Therapy Pad: YM2505, YJ25112 AUDODO Red Light Knee Brace: YM2501, YM2502, YM011, YM012 AUDODO Red Light Therapy Waist: YM2503 AUDODO Red Light Pad: YM010 Calming Heat (Copper Charcoal )Neck Wrap/Scarf Calming Heat Back Wrap CALMING HEAT SAUNA WRAP Calming Heat (Copper Charcoal)Flexi Wrap Calming Heat (Copper Charcoal) Shoulder Wrap Calming heat massaging Neck & Shoulder Wrap Calming Heat Weighted Heating Pad Calming heat Deluxe massaging Flexi Wrap Calming heat massaging Shoulder Wrap Calming heat Neck Wrap Calming heat massaging Neck wrap Calming Heat Charcoal copper heating pad-XXL Calming heat massaging Flexi Wrap Calming Heat Weighted Heating and Massaging Pad calming cozy Calming Heat Charcoal Copper Contour Pad Calming Heat Contour Pad Heating pad (detachable): SP23287L, SP23264H-G, SP23288M Calming heat Knee Wrap Calming Heat Weighted Massaging Heating Pad Calming Heat Charcoal copper heating pad Calming Heat (Copper Charcoal) Contour Pad Calming Heat (Copper Charcoal) Back Wrap/Pad Calming heat Flexi Wrap Calming Heat massaging weighted heating pad with jade stones

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	2025-07-28
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-12-19

Official Correspondent

Xianpeng Chen

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

TAIZHOU YUNKAI TECH 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021594370. Last updated year: 2026. Please use registration number 3021594370 when referencing this establishment in official correspondence.