Elbow
30 catalogue numbers from Adult Forearm, 70mm, 50mm Wrist, Flesh P, listed by Hugh Steeper Ltd, United Kingdom, under Joint, Elbow, External Limb Component, Mechanical. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Jiangsu (1). 2 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 |
| Metacare Industrial Ltd | Guangzhou | Guangdong | Contract manufacturer | 17 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Huzhou Universal Glove Company Limited | Huzhou | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Hugh Steeper Ltd, United Kingdom |
|---|---|
| FDA product code | IRD |
| Device type | Joint, Elbow, External Limb Component, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Adult Forearm, 70mm, 50mm Wrist, Flesh Pink | In distribution | |
| Adult Manual Elbow 70mm, Dark Brown | In distribution | |
| Lateral Ring Parallel 64mm | In distribution | |
| Automatic Elbow, Child, Flesh Pink | In distribution | |
| Right Medial -Auto Lock | In distribution | |
| Lateral Ring Parallel 58mm | In distribution | |
| Adult Forearm, 70mm, 50mm Wrist, Suntan | In distribution | |
| Left Medial → Manual Lock Flail Arm Application | In distribution | |
| Plain Joint Left Medial/Right Lateral- Free Swing | In distribution | |
| Right Medial Friction Steel | In distribution | |
| Plain Joint Right Medial/Left Lateral- Free Swing | In distribution | |
| Adolescent Forearm, 64mm, 50mm Wrist, Flesh Pink | In distribution | |
| Adult Forearm, 70mm, 54mm Wrist, Flesh Pink | In distribution | |
| Right Lateral Free Swing | In distribution | |
| Childs Forearm 58mm, 45mm Wrist, Suntan | In distribution | |
| Right Medial → Manual Lock Flail Arm Application | In distribution | |
| Automatic Elbow, Adult, Suntan | In distribution | |
| Automatic Elbow, Adult, Flesh Pink | In distribution | |
| Adolescent Forearm, 64mm, 50mm Wrist, Suntan | In distribution | |
| Automatic Elbow, Adolescent, Flesh Pink | In distribution | |
| Left Lateral Free Swing | In distribution | |
| Left Medial → Auto Lock | In distribution | |
| Automatic Elbow, Adolescent, Suntan | In distribution | |
| Left/Right Lateral Free Swing | In distribution | |
| Adult Manual Elbow 70mm, Flesh Pink | In distribution | |
| Left Medial Friction Steel | In distribution | |
| Child Friction Elbow 45mm | In distribution | |
| Lateral Ring 5inch Taper 70mm | In distribution | |
| Childs Forearm 58mm, 45mm Wrist, Flesh Pink | In distribution | |
| Child Friction Elbow 38mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Espire | Hugh Steeper Ltd | 36 |
| Copperfit | Ideavillage Products Corp. | 17 |
| Control and Suspension Systems | Hugh Steeper Ltd | 16 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Automatic Elbow | Hugh Steeper Ltd | 1 |
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.