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

CureWrap™ Infant, 4-7kg (Single)

Name: CureWrap™ Infant, 4-7Kg (single)
Brand: CureWrap™ Infant, 4-7Kg (single)

Catalogue number 500-03521, listed by Belmont Instrument Corp., United States, under System, Thermal Regulating. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

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 CureWrap™ Infant, 4-7Kg (single)
Listed by	Belmont Instrument Corp., United States
FDA product code	DWJ
Device type	System, Thermal Regulating
Device class	Class 2
Regulation	21 CFR 870.5900
510(k)	K083662
Record published	2016-09-24
Record revised	2026-04-16 (version 6)

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Box of 8, box of 4

Catalogue Numbers

Catalogue numbers for CureWrap™ Infant, 4-7Kg (single)
Catalogue number	Size	Status
500-03521		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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of CureWrap™ Infant, 4-7Kg (single)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Belmont Medical Technologies	510(k) number	2021-07-20	Class II	Component design/selection	Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregula	158 (US); 803 (OUS)

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.