DeRoyal

Active Wrap®, Shoulder, Post-OP

Registry build 21.09.26
178manufacturers in China registered for this device type
39catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (52), Jiangsu (45), Zhejiang (30). 26 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IME
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Picard Healthcare Technology (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Dongguan NAN YOU Sporting Goods Enterprise Ltd Dongguan Guangdong Contract manufacturer 23
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Zhejiang Changdi Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 16
Lianyungang Anson Non-woven Product Co., Ltd. Lianyungang Jiangsu Contract manufacturer 13

Showing 12 of 178. All 178 manufacturers in China registered for Pack, Hot Or Cold, Reusable

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code IME
Device type Pack, Hot Or Cold, Reusable
Device class Class 1
Regulation 21 CFR 890.5700
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-07-29
Record revised 2026-01-12 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 12, case of 48, case of 8, case of 24
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
9376-00 In distribution
9391-EXT In distribution
9378-01 In distribution
9390-03 In distribution
9390-00 In distribution
9393-04 In distribution
9392-05 In distribution
9398-02 In distribution
9373-01 In distribution
9372-02 In distribution
9390-02 In distribution
9392-04 In distribution
9374-01 In distribution
13-810A-23 In distribution
9375-00 In distribution
9373-02 In distribution
9373-04 In distribution
9372-01 In distribution
9371-XLS In distribution
9390-04 In distribution
9378-03 In distribution
9390-05 In distribution
9391-05 In distribution
9371-02 In distribution
9375-01 In distribution
9372-00 In distribution
9373-00 In distribution
13-810A-45 In distribution
9373-05 In distribution
9398-24 In distribution
9373-07 In distribution
9371-00 In distribution
9373-06 In distribution
9373-03 In distribution
9374-00 In distribution
9378-02 In distribution
9391-04 In distribution
9371-01 In distribution
9393-05 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bingfan Shanghai BingFan Industrial Co., Ltd. 69
Arctic Flex Vive Health LLC 62
Zhanzun Anhui Zhanzun Industrial Co., Ltd. 34
Vive Vive Health LLC 25
Sharper Image Merchsource LLC 25
Cryopush Chengdu Cryo-Push Medical Technology Co., Ltd. 23
Freeze Sleeve Jiangsu Huanyi Industrial Co., Ltd. 22
Polar Ice Brownmed 18
Squid Portable Therapeutix 15
Squid Go Portable Therapeutix 14
Squid Rx Portable Therapeutix 12
Bios Living Thermor Ltd. 12

Showing 12 of 191. All products under Pack, Hot Or Cold, Reusable

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