M-Brace Air
The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a…
The Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a unique construction technology, this innovative ankle stabilizer combines the ease of use of a mass-produced item with the effectiveness of a taping bandage. It is the only ankle brace with a posterior opening, allowing easy and painless application The brace offers a constant control of the inversion and eversion degree. Far from being cumbersome, it can easily fit any shoe and can be worn on either foot. INDICATIONS • Traumatic pathologies: distortions → tendonitis → luxations. • Rehab phase: passive support for the ankle functional rehab, it controls inversion and eversion movements of the ankle.
Who Else Makes It
Concentrated in Guangdong (34), Jiangsu (27), Zhejiang (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| 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 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
Showing 12 of 134. All 134 manufacturers in China registered for Joint, Ankle, External Brace
Record
| Listed by | Indaco SRL |
|---|---|
| FDA product code | ITW |
| Device type | Joint, Ankle, External Brace |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Premarket notification | Exempt |
| Record published | 2024-02-09 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17 L | In distribution | |
| 17 XXL | In distribution | |
| 17 S | In distribution | |
| 17 XL | In distribution | |
| 17 M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 480 |
| Medi | Medi Manufacturing Inc | 209 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 134 |
| CoreTech | Vive Health LLC | 118 |
| Vive | Vive Health LLC | 76 |
| Donjoy Performance | DJO, LLC | 60 |
| ManaMed | Manamed LLC | 49 |
| Profit | Pantymed S.A. | 43 |
| Push braces | Nea International B.V. | 39 |
| Tairuibosi | Tianjin Tairuibosi Medical Appliance Co., Ltd. | 36 |
| TruCompress | Vive Health LLC | 35 |
| BMI | Blake Manufacturing, Inc. | 32 |
Showing 12 of 414. All products under Joint, Ankle, External Brace
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.