Spark
Spark Kinetic Knee
7manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Fujian (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 |
|---|---|---|---|---|
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Zhejiang Qiangnao Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Huae Trade Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 10 |
| Baoji Shengtaike Industry & Trade Co., Ltd. | Baoji | Shanxi | Contract manufacturer | 7 |
| Dongguan Chuangguo Daily Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Brownmed, United States |
|---|---|
| FDA product code | ISY |
| Device type | Joint, Knee, External Limb Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40412 | In distribution | |
| 40420 | In distribution | |
| 40411 | In distribution | |
| 40421 | In distribution | |
| 40422 | In distribution | |
| 40410 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Capital | College Park Industries | 19 |
| Tehlin | TEH LIN Prosthetic & Orthopaedic, Inc. | 19 |
| Rheo Knee | Ossur Americas | 15 |
| Icon | College Park Industries | 13 |
| Slide.fit | Streifeneder ortho.production gmbH | 6 |
| Trulife | Trulife, Inc. | 6 |
| Power Knee | Ossur Americas | 5 |
| Guardian | College Park Industries | 5 |
| Imak Compression | Brownmed | 5 |
| Donjoy Performance | DJO, LLC | 4 |
| Victor | College Park Industries | 3 |
| Aura Plus | College Park Industries | 2 |
Showing 12 of 24. All products under Joint, Knee, External Limb Component
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.