DeRoyal
Foam Wrap, Shoulder
176manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (39), Jiangsu (38), Guangdong (21). 22 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
| Zhejiang Changdi Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Hanghai Medical Products Co Ltd | Jinhua | Zhejiang | Contract manufacturer | 10 |
Showing 12 of 176. All 176 manufacturers in China registered for Pack, Hot Or Cold, Disposable
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IMD |
| Device type | Pack, Hot Or Cold, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| 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
| 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, manufacturing date |
| Packaging | Case of 5, case of 4, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9385-00 | In distribution | |
| 9387-00 | In distribution | |
| HNICU-200 | In distribution | |
| 9381-00 | In distribution | |
| 9386-00 | In distribution | |
| 9381-10 | In distribution | |
| 9383-10B | In distribution | |
| 9381-10B | In distribution | |
| 9380-00 | In distribution | |
| 9384-00 | In distribution | |
| 9384-10 | In distribution | |
| 9383-10 | In distribution | |
| 9380-20 | In distribution | |
| 9383-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ANF Therapy® | Amino Frequency Corporation SL. | 47 |
| Cardinal Health | Cardinal Health 200, LLC | 44 |
| Medline | Medline Industries, Inc. | 24 |
| ThermaCare HeatWraps | Pfizer Inc | 19 |
| Halyard | Owens & Minor Distribution, Inc. | 15 |
| Halyard | O&M Halyard, Inc. | 14 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| HCS | Dyad Medical Sourcing, LLC | 13 |
| Novaplus | Cardinal Health 200, LLC | 13 |
| Curaplex | Bound Tree Medical, LLC | 13 |
| MediChoice | Owens & Minor Distribution, Inc. | 11 |
| PremierPro | Prestige Ameritech | 9 |
Showing 12 of 150. All products under Pack, Hot Or Cold, Disposable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K980509 | 1998-02-26 |
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.