Hand of Hope
Basic Information
- Brand Name
- Hand of Hope
- Primary DI
- 04897113220038
- Version / Model
- HOH4-SML-LR-W
- Company Name
- Rehab-Robotics Company Limited
- Labeler DUNS
- 663460271
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 9098c6f8-fc6a-4574-b641-047fc6742baf
Device Description
The Hand of Hope (HOH) is a therapy device (exoskeleton) used for neuromuscular rehabilitation of the hand and forearm. HOHfunctions as a biofeedback device where surface electromyography (sEMG) electrodes depict voluntary muscle activation. Thedepicted signals are processed and simplified, and can be seen by a convenient presentation of visual feedback. The sEMGreadout enables patients to monitor the fundamental neuromuscular functional state. Therefore, impairment, functional limitationand impaired volitional movement due to stroke or other neurologic or orthopaedic diseases can be easily presented and utilizedby a sensory signal. Patient’s attention is drawn to the task through a visually displayed sEMG signal and consequently used forthe initiation of the motor task. This biofeedback mechanism promotes motor learning via interactive use. In particular, stroke isone of the leading causes of adult disability, and hand rehabilitation after stroke is a very challenging part thereof. However, it iswell known that sensory signals such as visual sensory inputs reach the motor cortex and modulate motor cortex function andexcitability, and therefore can improve motor learning. Since active participation and initiation of the movement is the key tosuccess, using the biofeedback system, HOH motivates patients to actively interact with the system during an sEMG controlledtask-related training regime
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47517 | Virtual-display rehabilitation system, powered-support, upper-limb | An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04897113220038 | GS1 |