MedX
Isokinetic testing and evaluation system
9manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mateside Medical Devices Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 21 |
| Fourier Intelligence Inc. | Shanghai | Shanghai | Private-label distributor | 6 |
| Shanghai Siyi Intelligent Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Shanghai Zdroid Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Zhengzhou Angelexo Scientific Co., Ltd. | Zhengzhou | Henan | Manufacturer | 2 |
| Changsha Jinuo Intelligent Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 1 |
| Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
| Shenzhen Shengye Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
| Zhuhai Rehaconn Medical Co., Ltd. | Zhuhai | Guangdong | Specification developer | 1 |
Record
| Listed by | MedX Health Corp., Canada |
|---|---|
| FDA product code | IKK |
| Device type | System, Isokinetic Testing And Evaluation |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1925 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-05 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cervical | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Harmony SHR™ | Harmonic Bionics, Inc. | 12 |
| RPM2 Rx | Medhab, LLC | 8 |
| Trexo Robotics | Trexo Robotics, Inc. | 8 |
| Armeo | Hocoma AG | 7 |
| Lower extremity intelligent feedback training system for children | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 6 |
| Steprite | Medhab, LLC | 6 |
| Upper and lower limb active and passive motion assessment training instrument | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 4 |
| Fourier | Fourier Intelligence Inc. | 4 |
| Bioness Integrated System (BITS)2.0.5 | Bioness Medical, Inc. | 4 |
| Multi-joint isokinetic training and testing system | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 3 |
| Actiware | Respironics Inc. | 3 |
| Burt | Barrett Technology, LLC | 2 |
Showing 12 of 92. All products under System, Isokinetic Testing And Evaluation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K911666 | 1991-07-03 |
| K896553 | 1990-01-02 |
| K895236 | 1989-09-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-12-03 | Class II | Unknown/Undetermined by firm | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. | 4 | 2016-09-29 |
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.