Identity
- Trade Name
- rebless (Model: RHDB) FDA UDI
- Generic Name
- Continuous passive motion joint exerciser FDA UDI
- Device Name
- rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use. rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device. rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions. Key features: 1) Isokinetic: The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury. 2) Adjustable resistance: The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. 3) Adjustable assistance: The device provides a wide range of adjustable assistance settings, to apply assistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. FDA UDI
- Model / Reference
- RHDB FDA UDI
- Description
- rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use. rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device. rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions. Key features: 1) Isokinetic: The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury. 2) Adjustable resistance: The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. 3) Adjustable assistance: The device provides a wide range of adjustable assistance settings, to apply assistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. FDA UDI
Identifiers
- Catalog Number
- 1 FDA UDI
- Primary DI / UDI-DI
- 08800101600183 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Continuous passive motion joint exerciser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Continuous passive motion joint exerciser
rebless (Model: RHDB) by H Robotics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- H Robotics Inc.
Sources (1)
- FDA UDI c6660a7e-2667-4bca-8d3e-adc26654ef67 34 fields · synced May 30, 2026