What is FDA product code DWJ?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Cardiovascular › TherapeuticSystem, Thermal Regulating

40670 Hot Pink Pad Controller (Assembled)

Name: 40670 Hot Pink Pad Controller (Assembled)
Brand: 40670 Hot Pink Pad Controller (Assembled)

The Hot Pink Pad Controller operates the heating function of the Hot Pink Pad Warming System during surgery. Connected to a compatible single-use pad, it regulates pad temperature to assist…

Registry build 21.09.26

The Hot Pink Pad Controller operates the heating function of the Hot Pink Pad Warming System during surgery. Connected to a compatible single-use pad, it regulates pad temperature to assist patient temperature management and prevent inadvertent hypothermia in adult and pediatric patients.

The reusable controller allows temperature selection from 36 to 40°C in 0.5°C increments. It reads sensors integrated into the pad and adjusts energy delivery to maintain the selected setting. The front display shows the heated core temperature of the pad.

Monitoring and Reuse

Visual and audible alerts indicate faults, with independent overtemperature protection. The display does not measure patient body temperature. The controller mounts to an IV pole or similar support and requires cleaning and disinfection after each use in hospitals or surgery centers.

8manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWJ
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Copious Intl., Inc.	Heyuan, Guangdong Province		Contract manufacturer	11
Jiangyin Puremed	Jiangyin	Jiangsu	Contract manufacturer	7
Betacera Inc.	Suzhou	Jiangsu	Contract manufacturer	3
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Hangzhou Tappa Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	3
Jiangmen Dacheng Medical Equipment Co., Ltd.	Jiangmen	Guangdong	Contract manufacturer	1

Record

Regulatory record for 40670 Hot Pink Pad Controller (Assembled)
Listed by	Xodus Medical, Inc., United States
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K260903
Record published	2026-04-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, serial number
Packaging	Case

Catalogue Numbers

Catalogue numbers for 40670 Hot Pink Pad Controller (Assembled)
Catalogue number	Size	Status
40670		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mistral-Air	The Surgical Company International B.V.	114
Bair Hugger™	3M Company	99
IOB	Jiangmen Dacheng Medical Equipment Co., Ltd.	68
IOB	Iob Medical, Inc.	61
3M™ Bair Hugger™	3M Company	61
Cocoon	Care Essentials PTY Ltd	59
Soft Air	Adroit Medical Systems, Inc.	56
Level 1	ICU Medical, Inc	49
System, Thermal Regulating	Hangzhou Tappa Medical Technology Co., Ltd.	47
PremierPro	Prestige Ameritech	39
Bair Paws™	3M Company	30
SourceMark	Sourcemark, LLC.	25

Showing 12 of 166. All products under System, Thermal Regulating

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260903	2026-04-16

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.