Bioness Integrated System (Bits) Mobile Configuration
Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software
9manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Bioness Medical, Inc., United States |
|---|---|
| FDA product code | IKK |
| Device type | System, Isokinetic Testing And Evaluation |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1925 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIT-2224 | In distribution | |
| BIT-2224 | 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
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.