FDA Device Intelligence
HomeH ROBOTICS INC. › rebless (Model: RHDB)

rebless (Model: RHDB)

H ROBOTICS INC. · Model RHDB · UDI-DI 08800101600183

IKK
10
510(k) clearances
47
Adverse events
4
Recalls
57
Facilities

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.

Recalls

DateFirmReason
2023-05-31Trexo Robotics Holdings Inc.Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
2020-06-08Hocoma AGThe motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol
2013-12-03MedX Holdings, Inc.Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05Interactive Motion Technologies, Inc.Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.