Unite Medical®
Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and…
Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility.
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 | Unite Medical, LLC, United States |
|---|---|
| FDA product code | ITW |
| Device type | Joint, Ankle, External Brace |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-28 |
| Record revised | 2024-08-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ankle Foot Orthosis (Right,Medium) | In distribution | |
| Heel Stabilizer (XLarge) | In distribution | |
| Tall Walking Boot – Pneumatic (Large) | In distribution | |
| Ankle Foot Orthosis (Left, Medium) | In distribution | |
| Heel Stabilizer (Large) | In distribution | |
| Tall Walking Boot – Pneumatic (Medium) | In distribution | |
| Short Walking Boot – Pneumatic (Large) | In distribution | |
| Short Walking Boot – Pneumatic (Small) | In distribution | |
| Ankle Foot Orthosis (Left, Large) | In distribution | |
| Short Walking Boot – Pneumatic (Medium) | In distribution | |
| Tall Walking Boot – Pneumatic (Small) | In distribution | |
| Tall Walking Boot – Pneumatic (XSmall) | In distribution | |
| Heel Stabilizer (Medium) | In distribution | |
| Ankle Foot Orthosis (Left, Small) | In distribution | |
| Short Walking Boot – Pneumatic (XLarge) | In distribution | |
| Ankle Foot Orthosis (Right,Large) | In distribution | |
| Tall Walking Boot – Pneumatic (XLarge) | In distribution | |
| Short Walking Boot – Pneumatic (XSmall) | In distribution | |
| Heel Stabilizer (Small) | In distribution | |
| Ankle Foot Orthosis (Right,Small) | 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.