Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010168054

FEI Number

3010168054

Entity Name

Jiangmen Dacheng Medical Equipment Co., Ltd.

City/State/Country

Jiangmen Guangdong, CN

Establishment Address

#8 South of Jiaobei Hengkeng, Jianghai District, Jiangmen Guangdong 529000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gentherm Medical LLC (Owner Number: 10042384)

Owner / Operator Contact Address

12011 Mosteller Road, Cincinnati, OH 45241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IOB Warming Blankets IOB-304/IOB-304S Extra Large Size Warming Suit IOB-001/IOB-001S Torso Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket IOB-024/IOB-024S Jackson Warming Blanket IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket IOB-003/IOB-003S Upper Body Warming Blanket IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-027/IOB-027S Large Full Body Warming Blanket KoZee Under Body Warming Blanket, M21005 KoZee Small Warming Suit, M21301 IOB-018/IOB-018S Multi-Access Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket IOB-017/IOB-017S Chest Access Warming Blanket IOB-026/IOB-026S Large Half Body Warming Blanket KoZee Full Body Surgical Warming Blanket Postoperative, M21008 KoZee Lower Body Warming Blanket Pediatric, M21012 IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-011/IOB-011S Lithotomy Under Body Warming Blanket IOB-023/IOB-023S Cardiac Warming Blanket KoZee Adult Full Body Warming Blanket Postoperative, M21004 KoZee Lithotomy&Orthopedic Under Body Warming Blanket, M21029 IOB-302/IOB-302S Medium Size Warming Suit KoZee Large Warming Suit, M21303 IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-004/IOB-004S Full Body Warming Blanket KoZee Full Access Under Body Warming Blanket, M21006 IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-022/IOB-022S Outpatient Care Warming Blanket KoZee Full Body Warming Blanket Postoperative, M21007 IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket KoZee Long Warming Blanket Pediatric, M21014 IOB Temperature Management System Model IOB-507 IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket KoZee Spinal Under Body Warming Blanket, M21010 IOB-301/IOB-301S Small Size Warming Suit KoZee Extra Large Warming Suit, M21304 KoZee Warming Unit M21507 IOB-034/IOB-034S Arms-in Upper Body Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket KoZee Multi-Position Upper Body Blanket, M21030 KoZee Cardiac Access Warming Blanket Other, M21020 KoZee Medium Warming Suit, M21302 KoZee Cath Lab Warming Blanket Other, M21015 KoZee Surgical Access Warming Blanket Other, M21016 KoZee Lower Body Warming Blanket Intraoperative, M21002 KoZee Infant Under Body Warming Blanket, M21028 KoZee XL Upper Body Warming Blanket Intraoperative, M21021 KoZee Large Under Body Warming Blanket, M21009 KoZee Torso Warming Blanket Intraoperative, M21001 KoZee Infant Full Body & Upper Body Warming Blanket, M21025 KoZee Upper Body Blanket, M21003

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2023-01-22
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2023-07-03

Official Correspondent

Angie Gegner

US Agent Details

Jonathan Kovach Business: Gentherm Medical LLC Email: jonathan.kovach@gentherm.com Phone: (513) 3265295

Related Public Records

Same Entity

Gentherm Medical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1516825	Gentherm Medical, LLC	Cincinnati, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
2432320	NOVAMED-USA	Elmsford, NY, US
3012315097	CARE ESSENTIALS INTERNATIONAL PVT LTD.	Ahmedabad Gujarat, IN
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010168054. Last updated year: 2026. Please use registration number 3010168054 when referencing this establishment in official correspondence.