M-Brace Air
This Wrist Splint has been designed and produced as a support and protective device for muscular damages, as well as for tendon and joint injuries either caused by trauma, stress or…
This Wrist Splint has been designed and produced as a support and protective device for muscular damages, as well as for tendon and joint injuries either caused by trauma, stress or excessive fatigue. Available in right or left for a perfect fit and superior comfort. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to this specific construction, a vast range of closing positions are available, depending on the tension desired. The two aluminum stays, pre-shaped and moldable for custom fitting, can be removed according to the need of immobilization of the patient.
Who Else Makes It
Concentrated in Guangdong (36), Zhejiang (32), Jiangsu (30). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
Showing 12 of 144. All 144 manufacturers in China registered for Splint, Hand, And Components
Record
| Listed by | Indaco SRL |
|---|---|
| FDA product code | ILH |
| Device type | Splint, Hand, And Components |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Premarket notification | Exempt |
| Record published | 2024-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box case of 12, box case of 16, box case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35 LS | In distribution | |
| 134 LE | In distribution | |
| 137 L | In distribution | |
| 35 RS | In distribution | |
| 134 RE | In distribution | |
| 35 RE | In distribution | |
| 35 LE | In distribution | |
| 136 RE | In distribution | |
| 136 LR | In distribution | |
| 136 RR | In distribution | |
| 137 R | In distribution | |
| 35 LR | In distribution | |
| 35 RR | In distribution | |
| 134 LR | In distribution | |
| 134 RR | In distribution | |
| 136 LE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 1,511 |
| Splint, Hand, And Components | Tetra Medical Supply Corp. | 111 |
| Plastalume | Brownmed | 102 |
| BMI | Blake Manufacturing, Inc. | 87 |
| Panacea | Blake Manufacturing, Inc. | 78 |
| Klarity Medical | Klarity Medical Products, LLC | 65 |
| Vive | Vive Health LLC | 61 |
| McKie Thumb Splint Pediatric | Mckie Splints, LLC | 60 |
| Performance Health | ASP Global, LLC | 59 |
| McKie Thumb Splint Adult | Mckie Splints, LLC | 47 |
| Wrist Lacer | Medical Specialties, Inc. | 38 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 34 |
Showing 12 of 254. All products under Splint, Hand, And Components
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.