TM “Rehabilitimed” RP-6K-M1 UNIp-1 Comfort
It is an orthosis for the shoulder and elbow joint, graphite color. Made of multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton…
It is an orthosis for the shoulder and elbow joint, graphite color. Made of multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation.
Who Else Makes It
Concentrated in Guangdong (18), Zhejiang (13), Jiangsu (13). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| 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 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Yangzhou Juli Sports Articles Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 16 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Hengshui Tianjian Medical Supplies Co., Ltd. | Shenzhou | Hebei | Contract manufacturer | 14 |
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 72. All 72 manufacturers in China registered for Support, Arm
Record
| Listed by | Reabilitimed TOV |
|---|---|
| FDA product code | IOY |
| Device type | Support, Arm |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Premarket notification | Exempt |
| Record published | 2025-05-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RP-6K-M1 UNIp-1 Comfort | Child’s age: from 2 to 5 years | In distribution |
| RP-6K-M1 UNIp-1 Comfort | Chest circumference with arm pressed (inch): 21-23,5 | In distribution |
| RP-6K-M1 UNIp-1 Comfort | Chest circumference with arm pressed (inch): 21-23,5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Juzo Soft | Julius Zorn, Inc. | 432 |
| Juzo Dynamic | Julius Zorn, Inc. | 312 |
| Juzo Soft Seamless | Julius Zorn, Inc. | 272 |
| Juzo Custom Compression Garments | Julius Zorn, Inc. | 94 |
| Juzo Expert | Julius Zorn, Inc. | 63 |
| Juzo Ortho Supports | Julius Zorn, Inc. | 36 |
| Juzo Suspension Sleeve | Julius Zorn, Inc. | 30 |
| Juzo Basic Seamless | Julius Zorn, Inc. | 24 |
| Rhino | MD Orthopaedics | 19 |
| Medi | Medi Manufacturing Inc | 11 |
| Walgreens | Walgreen Co. | 11 |
| Elbow Sleeve Neoprene | Alimed, LLC | 4 |
Showing 12 of 52. All products under Support, Arm
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.