Coapt Evaluation Kit
The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and…
The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket.
Who Else Makes It
Concentrated in Fujian (2), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| T&L (Jiaxing) Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 4 |
| Fujian Guozi Rehabilitation Medical Co., Ltd. | Fuzhou | Fujian | Manufacturer | 2 |
Record
| Listed by | Coapt LLC, United States |
|---|---|
| FDA product code | IQO |
| Device type | Device, Prosthesis Alignment |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoskeletal Components | College Park Industries | 102 |
| Juzo SoftCompress | Julius Zorn, Inc. | 19 |
| Osseointegration Prosthetic Limb | Osseointegration International Pty Ltd | 13 |
| C100 Cylindrical Shuttle Lock | College Park Industries | 13 |
| Juzo Night | Julius Zorn, Inc. | 12 |
| Torsion Adapter | College Park Industries | 6 |
| LA Liner, Pin, Tapered, 9mm, Medium | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 6mm, Large | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 3mm, Medium+ | Silipos Holding LLC | 2 |
| Duragel Pin Liner, Uniform, 9mm, Medium | Silipos Holding LLC | 2 |
| LA Liner, Pin, Uniform, 3mm, Large+ | Silipos Holding LLC | 2 |
| LA Liner, Pin, Tapered, 3mm, Medium+ | Silipos Holding LLC | 2 |
Showing 12 of 38. All products under Device, Prosthesis Alignment
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.