Real Immersive System
REAL Immersive System uses virtual environments and tracked avatars for upper-extremity rehabilitation. Electromagnetic sensors track the patient’s movements, translating them into visual…
REAL Immersive System uses virtual environments and tracked avatars for upper-extremity rehabilitation. Electromagnetic sensors track the patient’s movements, translating them into visual feedback in the virtual scene.
The hardware includes a head-mounted display, controller, wireless sensor and transmitter modules, tablet, router and sensor bands. Software on the display and tablet supports the rehabilitation platform.
Listed Item
REAL Immersive System, Eval Use
Supervised Exercise and Feedback
The intended use is prescribed rehabilitation exercises for adults seated in a clinical environment under a trained rehabilitation professional’s supervision. The system reports movement measures such as joint-angle changes, giving the clinician information alongside the patient’s visual feedback.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bliss Health Products Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 19 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Note Electronics (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Shaoxing Reborn Medical Devices Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 14 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Shanghai Wanbo Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 8 |
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Exerciser, Measuring
Record
| Listed by | Penumbra Inc., United States |
|---|---|
| FDA product code | ISD |
| Device type | Exerciser, Measuring |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K183296 |
| Record published | 2020-06-17 |
| Record revised | 2021-06-08 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REAL1 | In distribution | |
| RLY1S-A | In distribution | |
| REAL1V-A | In distribution | |
| REAL1S-A | In distribution | |
| RLY1-A | In distribution | |
| RLY1V-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lode B.V. | Lode B.V. | 27 |
| Digital Therapist | Sword Health S.A. | 10 |
| VRPhysio | XR Health IL Ltd | 7 |
| DS6 | Foresite Healthcare, LLC | 5 |
| Kintinuum™ | Mc10, Inc. | 4 |
| XRBehavior | XR Health IL Ltd | 4 |
| VRReliever | XR Health IL Ltd | 3 |
| Real y-Series | Penumbra Inc. | 3 |
| ActiGraph | ActiGraph L.L.C. | 2 |
| Sword Phoenix | Sword Health S.A. | 2 |
| Exer Scan | Exer Labs, Inc. | 2 |
| WalkVR | Virtualis | 1 |
Showing 12 of 207. All products under Exerciser, Measuring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183296 | 2019-03-18 |
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.