Thermoflect

Thermoflect MD Blkt KIT, 20EA TS Thermoflect KIT, MED Blkt, Adult CAP, 2 Leggings, 4 BG/CS

Registry build 21.09.26
308manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (73), Zhejiang (56), Hubei (49). 65 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KME
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21

Showing 12 of 308. All 308 manufacturers in China registered for Bedding, Disposable, Medical

Record

Regulatory record for Thermoflect
Listed by Encompass Group, L.L.C.
FDA product code KME
Device type Bedding, Disposable, Medical
Device class Class 1
Regulation 21 CFR 880.6060
Premarket notification Exempt
Record published 2022-11-03
Record revised 2023-05-05 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Case of 25, pack of 5, case of 10, case of 5, case of 12, case of 24

Catalogue Numbers

Catalogue numbers for Thermoflect
Catalogue number Size Status
5400-230 In distribution
5100-200 In distribution
5200-700 In distribution
5170-150 In distribution
5115-200 In distribution
5200-400 In distribution
5400-210 In distribution
5200-800 In distribution
5105-100 In distribution
5170-200 In distribution
5100-700-DOD In distribution
5000-830 In distribution
5100-700 In distribution
5400-100 In distribution
5100-400 In distribution
5105-200 In distribution
5100-250 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wings Cardinal Health 38
Curaplex Bound Tree Medical, LLC 37
Alleset GRI Medical & Electronic Technology Co., Ltd. 34
PremierPro Prestige Ameritech 22
Allen Hill-ROM, Inc. 20
AllCare Allcare, Inc. 18
Cardinal Health Cardinal Health 200, LLC 18
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 17
Action® Action Products, Inc. 15
Novaplus Cardinal Health 14
Primo/ASP Medical ASP Global, LLC 13
Emsrun Wuxi Emsrun Technology Co., Ltd. 13

Showing 12 of 228. All products under Bedding, Disposable, Medical

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer