Bits FR
BITS Functional Reality Clinician Software
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Shanghai Zdroid Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Guangzhou Sowen Digital Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
Record
| Listed by | Bioness Medical, Inc., United States |
|---|---|
| FDA product code | QKC |
| Device type | Interactive Rehabilitation Exercise Device, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIT-4001 | In distribution | |
| BIT-4000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kemtai Care | Kemtai | 5 |
| Reality DTx | Strolll, Inc. | 4 |
| Vertigenius | Digital Rehabilitation Limited | 3 |
| MindMotion GO Procedure Pack | NeuroXtherapeutics SA | 2 |
| Strolll Rehab | Strolll, Inc. | 1 |
| MindPod Dolphin | NeuroXtherapeutics SA | 1 |
| EverEx Rehab | Everex SRL | 1 |
| YourSteps | Yoursteps Health, Inc. | 1 |
| Exer Health | Exer Labs, Inc. | 1 |
| VSTBalance | Virtusense | 1 |
| Exer Physio | Exer Labs, Inc. | 1 |
| GaitSmart® | Dynamic Metrics Limited | 1 |
Showing 12 of 22. All products under Interactive Rehabilitation Exercise Device, Prescription Use
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.