DeRoyal
Acromioclavicular Splint
31manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Fujian (7), Jiangsu (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
Showing 12 of 31. All 31 manufacturers in China registered for Splint, Clavicle
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IQJ |
| Device type | Splint, Clavicle |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-23 |
| Record revised | 2024-08-20 (version 3) |
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 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3004-06 | In distribution | |
| 3002-05 | In distribution | |
| 3015-04 | In distribution | |
| 403S10 | In distribution | |
| 3015-15 | In distribution | |
| 3004-14 | In distribution | |
| 3015-05 | In distribution | |
| 3002-04 | In distribution | |
| 3002-01 | In distribution | |
| 3004-01 | In distribution | |
| 3015-12 | In distribution | |
| 3015-03 | In distribution | |
| 3001-02 | In distribution | |
| 405S10 | In distribution | |
| 3002-02 | In distribution | |
| 3001-06 | In distribution | |
| 3001-05 | In distribution | |
| 3015-13 | In distribution | |
| 3015-02 | In distribution | |
| 3004-05 | In distribution | |
| 406S10 | In distribution | |
| 3004-03 | In distribution | |
| 3007-00 | In distribution | |
| 3004-12 | In distribution | |
| 3004-02 | In distribution | |
| 3002-06 | In distribution | |
| 499S10 | In distribution | |
| 3004-15 | In distribution | |
| 3002-03 | In distribution | |
| 3001-01 | In distribution | |
| 3001-04 | In distribution | |
| 3015-01 | In distribution | |
| 3004-16 | In distribution | |
| 3001-03 | In distribution | |
| 3004-13 | In distribution | |
| 497S10 | In distribution | |
| 3004-04 | In distribution | |
| 3004-11 | In distribution | |
| 404S10 | In distribution | |
| 3015-11 | In distribution | |
| 3015-14 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhino | MD Orthopaedics | 23 |
| NON Franchise | DJO, LLC | 3 |
| Mecron Shoulder Classic | Darco (Europe) GmbH | 2 |
| Mecron Shoulder Universal | Darco (Europe) GmbH | 2 |
| Mecron Shoulder Neopren | Darco (Europe) GmbH | 2 |
| Comfor Clavicle W/Hook & Loop XL | Bird & Cronin, LLC | 1 |
| Clavicle Brace W/Velcro XXS | Bird & Cronin, LLC | 1 |
| Mecron Shoulder-Hand Sonderanfertigung | Darco (Europe) GmbH | 1 |
| Clavicle Brace W/Velcro SM | Bird & Cronin, LLC | 1 |
| Comfor Clavicle W/Hook & Loop XS | Bird & Cronin, LLC | 1 |
| Comfor Clavicle W/Hook & Loop XXS | Bird & Cronin, LLC | 1 |
| TM “Rehabilitimed” OT-2 UNI Comfort | Reabilitimed TOV | 1 |
Showing 12 of 23. All products under Splint, Clavicle
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.