Espire
55 catalogue numbers from Espire Elbow Pro- Left- Jet Black- Stand, listed by Hugh Steeper Ltd, United Kingdom, under Joint, Elbow, External Limb Component, Powered. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
55catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Hugh Steeper Ltd, United Kingdom |
|---|---|
| FDA product code | IRE |
| Device type | Joint, Elbow, External Limb Component, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K182757 |
| Record published | 2023-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Espire Elbow Pro- Left- Jet Black- Standard | In distribution | |
| Espire Elbow Pro- Right- Black Carbon Finish- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Lateral Dial- Standard- COAPT | In distribution | |
| Espire Elbow Pro- Right- Black Carbon Finish- Small | In distribution | |
| Espire Elbow Hybrid- Right- Black Carbon Finish- Lateral Dial- Standard- COAPT | In distribution | |
| Espire Elbow Pro- Left- Black Carbon Finish- Small | In distribution | |
| Espire Elbow Pro- Right- Black Carbon Finish- Small- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Lateral Dial- Small- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Medial Dial- Small- COAPT | In distribution | |
| Espire Elbow Pro- Left- Caucasian- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Caucasian- Medial Dial- Small | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Standard | In distribution | |
| Espire Elbow Pro- Right- Brown- Standard | In distribution | |
| Espire Elbow Hybrid- Right- Black Carbon Finish- Medial Dial- Standard | In distribution | |
| Espire Elbow Pro- Left- White- Standard- COAPT | In distribution | |
| Espire Battery Car Charger-US | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Medial Dial- Small | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Medial Dial- Small | In distribution | |
| Espire Elbow Pro- Right- Silver- Small- COAPT | In distribution | |
| Espire Elbow Pro- Right- Caucasian- Small | In distribution | |
| Espire Elbow Pro- Left- Caucasian- Small | In distribution | |
| Espire Elbow Pro- Left- Caucasian- Standard | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Small- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Medial Dial- Standard | In distribution | |
| Espire Elbow Hybrid- Right- Caucasian- Medial Dial- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Medial Dial- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Standard- COAPT | In distribution | |
| Espire Bump Switch | In distribution | |
| Espire Elbow Hybrid- Left- Caucasian- Medial Dial- Standard | In distribution | |
| Espire Battery | In distribution | |
| Espire Elbow Hybrid- Left- Jet Black- Medial Dial- Small- COAPT | In distribution | |
| Espire Elbow Pro- Left- Jet Black- Small | In distribution | |
| Espire Elbow Pro- Left- Jet Black- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Lateral Dial- Standard | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Lateral Dial- Small | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Medial Dial- Small- COAPT | In distribution | |
| Espire Elbow Pro- Left- Black Carbon Finish- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Brown- Lateral Dial- Small | In distribution | |
| Espire Elbow Pro- Right- Jet Black- Standard- COAPT | In distribution | |
| Espire Elbow Pro- Right- Jet Black- Small | In distribution | |
| Espire Elbow Pro- Right- Jet Black- Standard | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Medial Dial- Standard | In distribution | |
| Espire Elbow Hybrid- Right- Caucasian- Medial Dial- Small | In distribution | |
| Espire Battery Charger- Single Bay- US | In distribution | |
| Espire Elbow Pro- Right- Jet Black- Small- COAPT | In distribution | |
| Espire Elbow Hybrid- Right- Caucasian- Lateral Dial- Standard | In distribution | |
| Espire Elbow Pro- Left- Black Carbon Finish- Small- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Black Carbon Finish- Medial Dial- Standard- COAPT | In distribution | |
| Espire Elbow Hybrid- Left- Caucasian- Lateral Dial- Standard | In distribution | |
| Espire Elbow Pro- Right- Black Carbon Finish- Standard | In distribution | |
| Espire Elbow Hybrid- Left- Jet Black- Medial Dial- Standard | In distribution | |
| Espire Battery Charger- Dual Bay- US | In distribution | |
| Espire Elbow Hybrid- Right- Jet Black- Medial Dial- Standard | In distribution | |
| Espire Elbow Pro- Right- Caucasian- Standard | In distribution | |
| Espire Elbow Pro- Left- Black Carbon Finish- Standard | In distribution |
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.