Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034397207

FEI Number

3034397207

Entity Name

Ezra Innovation (Dong guan) Limited

City/State/Country

DongGuan City Guangdong, CN

Establishment Address

No.27,XingTai Road, HengLi Town, DongGuan City Guangdong 523478, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ezra Innovation (Dong guan) Limited (Owner Number: 10092126)

Owner / Operator Contact Address

No.27,XingTai Road, HengLi Town,, DongGuan City, CN-GD 523478, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HP01XG (Type TR10) HPO8FWX F00055, F00056, F00077, F00155, F00156, F00174, F00177, F00255, F00355, F00356 F00377 852, 853, 812, 832, F00695, F00245, F00655

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-12-06
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2025-12-22

Official Correspondent

William Slevin

US Agent Details

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

Related Public Records

Same Entity

Ezra Innovation (Dong guan) Limited

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

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034397207. Last updated year: 2026. Please use registration number 3034397207 when referencing this establishment in official correspondence.