Mecron Shoulder Neopren
universal Blue right
31manufacturers in China registered for this device type
2catalogue 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 | Darco (Europe) GmbH, Germany |
|---|---|
| FDA product code | IQJ |
| Device type | Splint, Clavicle |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-08 |
| Record revised | 2025-07-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS102000 | In distribution | |
| OS102100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 41 |
| Rhino | MD Orthopaedics | 23 |
| NON Franchise | DJO, LLC | 3 |
| Mecron Shoulder Classic | Darco (Europe) GmbH | 2 |
| Mecron Shoulder Universal | 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.