RxDecom® Spinal Decompression Machine
| Item | Detail |
|---|---|
| Device | RxDecom® |
| Category | Spinal distraction and spinal decompression |
| Intended setting | Trained rehabilitation and clinical environments |
| Main features | Servo control, load measurement, touchscreen HMI, split-table design, high-low access |
| Component systems | Yaskawa, OMRON, Transducer Techniques, Pro-face, Schneider Electric, LINAK |
The RxDecom® by TheraMod™ is our flagship spinal distraction and spinal decompression medical device specifically tailored for professional healthcare usage in formal neuro-musculoskeletal disciplines, specifically including: orthopedics, physiotherapy, chiropractic, and osteopathy.
TheraMod™ recommends RxDecom® for use in professional healthcare settings such as clinics, hospitals, and specialist centers by registered and licensed providers only.
RxDecom® has been developed to be utilized as either standalone equipment or as integrated rehabilitation equipment with seamless compatibility among all other medical devices manufactured by TheraMod™.
View the complete rehabilitation equipment portfolio of medical equipment manufactured by TheraMod™
Key Takeaways
| Point | What it means |
|---|---|
| What it is | A Class A controlled spinal distraction device for the cervical and lumbar regions. |
| Who operates it | Trained operators and qualified practitioners, during professionally supervised sessions. |
| Where it is used | Chiropractic, physiotherapy, rehabilitation, and traditional and complementary healthcare settings. |
| How force is governed | Servo-driven motion with continuous load measurement and a force-related feedback loop. |
| Table design | Split-bed construction, swivel rotation, height adjustment and adjustable patient positioning. |
| Registration | Registered under the Medical Device Act 2012 (Act 737). Registration GA10689826-235584, valid to 1 July 2031. |
| Quality system | Built under an ISO 13485 quality management system certified by TÜV SÜD. |
Class A Controlled Spinal Distraction Device
The RxDecom® is registered as a Class A controlled spinal distraction device intended to support the application of controlled distraction to the cervical or lumbar region during professionally supervised sessions. It is intended for use by trained operators and qualified practitioners in permitted professional settings, including chiropractic, physiotherapy, rehabilitation, and traditional and complementary healthcare environments where local laws and facility procedures allow such use.
RxDecom® For Cervical Spinal Distraction
Cervical spinal distraction and decompression provided by RxDecom® administers a gentle distractive pulling force with dynamic mass intervals from a minimum of 7kg to a maximum of 12kg for cervical spine protocols. RxDecom® offers a flexible spinal decompression angle from 0° to a maximum of 18° for cervical spine protocols.
The integrated cervical support system of RxDecom® has been engineered by TheraMod™ to accommodate a broad range of patient presentations and anthropometric profiles. Its adjustable configuration is designed to support appropriate cervical positioning and patient comfort across varying body dimensions. The RxDecom® can comfortably accommodate users up to 223.52cm (88in) in height and a maximum weight-limit of 125kg (275.58lbs).
The RxDecom® aims to provide a gentle distractive pull, allowing segmental mobilization and decompression in a manner that helps avoid the typical muscle guarding often experienced during mechanized or manual cervical distractive methods.
RxDecom® For Lumbar Spinal Distraction
Similarly to the cervical protocol, RxDecom® lumbar spinal decompression and distraction directs a moderate distractive pulling force with dynamic mass intervals from a minimum of 14kg to a maximum of 37.5kg for lumbar spine protocols. RxDecom® offers a wide angle of spinal distraction from 0° to a maximum of 30° for lumbar spine protocols.
For lumbar spinal decompression, RxDecom® is used in conjunction with a dedicated Thoracic Harness and Lumbar Harness designed to provide secure pelvic and trunk fixation during treatment. Proper harness selection is essential to optimize patient positioning, minimize unwanted movement, and facilitate controlled application of decompressive force to the lumbar spine. Each RxDecom® harness system is supplied in the following sizes to accommodate a range of patient anthropometric measurements:
| Harness | Size | Fitting range |
|---|---|---|
| Thoracic | Small (S) | Chest circumference |
| Thoracic | Medium (M) | Chest circumference |
| Thoracic | Large (L) | Chest circumference |
| Lumbar | Small (S) | Waist circumference |
| Lumbar | Medium (M) | Waist circumference |
| Lumbar | Large (L) | Waist circumference |
Fitting ranges in centimeters and inches for each harness size will be published here once confirmed.
Spinal distractive care by the RxDecom® aims to provide decompression for mechanical lumbar issues with gentle and targeted methods. The RxDecom® can comfortably accommodate users up to 223.52cm (88in) in height and a maximum weight-limit of 125kg (275.58lbs).
Controlled Engineering For Professional Use
RxDecom® was developed around the practical requirements of trained healthcare professional operation:
- Controlled actuator movement up to 58° vertical tilt for ease of patient positioning.
- Structured setup via input from advanced single-touch user interface display.
- Installation, training guidelines, maintenance and service planning provided by TheraMod™.
- Adjustable positioning and ergonomics support to meet requirements and needs of the general population.
Computer Assisted Motion Control
RxDecom® incorporates a servo-controlled movement system managed through the device’s control architecture.
The servo system supports:
- Defined device movement
- Controlled changes in operating parameters
- Repeatable parameter settings
- Programmed operating sequences
- Integration with the device’s monitoring and user-interface functions.
The operator remains responsible for patient assessment, suitability, setup, parameter selection, observation, and use of the device in accordance with the current instructions for use.
Dynamic Force-Related Feedback Loop
RxDecom® incorporates programmable logic control and sensor components within its architecture. Integrated load measurement components provide force-related operating data that can be viewed and monitored by trained operators. This supports a more structured approach to parameter setting and operating oversight.
Professional Touch Interface
The single touch full-color display screen integrated into RxDecom® provides a central location for trained operators to input, review, and monitor defined operating parameters.
The interface supports:
- Structured device setup
- Parameter review
- Programmed operation
- Professional-operator training
- Troubleshooting
- Service procedures
- Documentation of the operating workflow where enabled
The interface does not replace professional assessment or operator responsibility.
Swivel-Rotation and Height-Adjustable
The RxDecom® table and positioning system supports a controlled transition in horizontal and vertical planes of motion. This configuration is intended to support ease of professional setup and workflow for both the users and operators. Table movement must be performed by a trained operator and within the limits defined by the current operating documentation.
On the horizontal plane, the RxDecom® bed can be rotated to be positioned in 0° or 180° positions, achievable via either clockwise or counterclockwise movements. Vertically, the RxDecom® can reach a maximum of 58° vertical tilt from baseline via controlled actuator movements.
The RxDecom® has been certified by TheraMod™ to have a maximum weight capacity of 125kg for users.
Split-Bed Functionality
RxDecom® includes a split-bed configuration designed to support segmented positioning and controlled table movement during professional operation.
The split-bed functionality allows the bed to separate into two sections up to 13 cm during selected lumbar sessions during controlled distraction or decompression allowing for less friction for the user’s lower back, enhancing comfort and decompressive effects.
This feature can be activated or deactivated depending on the operator’s preference.
Adjustable Patient Positioning
The device includes adjustable table and tower-positioning functions that allow trained operators to configure the system within its documented operating range.
This supports professional setup for different body sizes and defined equipment-use requirements.
Regulatory Compliance
RxDecom® is registered as a Class A controlled spinal distraction device in the country of manufacture.
- Registered under: Medical Device Act 2012 (Act 737)
- Registration number: GA10689826-235584
- Validity period: 2 July 2026 to 1 July 2031
- Manufacturer establishment licence: MDA-5532-K124, valid 5 March 2024 to 4 March 2027
The registered intended-use statement and approved claims for RxDecom® are held in the current registration and in the controlled instructions for use supplied with the device. Licensed practitioners and institutional buyers can request the current wording from TheraMod using the TheraMod contact page.
ISO Certification
ISO 13485 is the international standard for quality management systems in medical device manufacturing. It sets requirements for design control, risk management, document control, production records, traceability, and post-market monitoring. A manufacturer that holds a valid ISO 13485 certificate has been audited by an independent certification body against those requirements.
TheraMod holds ISO 13485 certification for the design, development, and manufacture of rehabilitation systems for the treatment and rehabilitation of spinal related ailments. Both certificates are issued by TÜV SÜD and are reproduced below.
For a professional buyer this matters in three practical ways. It confirms that RxDecom® is built under a controlled and audited process. It supports market access, because many regulators and tender processes require an ISO 13485 certified manufacturer. It also supports service continuity, because the standard requires records, traceability, and change control to be kept for each device.
These records confirm quality system scope and manufacturing control. They do not establish clinical outcomes, comparative superiority, authorization in another market, or MDA endorsement.
Certificates and Licences
Certificate 1. ISO 13485:2016, TÜV SÜD
Certificate 2. EN ISO 13485, TÜV SÜD Product Service
Certificate 3. Medical Device Registration Certificate, RxDecom®
Certificate 4. Manufacturer Establishment Licence
Read these four records together. Two of them cover the quality system that governs how the device is made. One covers the registration of the device itself. One covers the licence that lets us manufacture at all. Each carries its own reference number and expiry date, so any of them can be checked against the body that issued it.
They establish quality system scope, manufacturing control, and registration status. They do not establish clinical outcomes, comparative superiority, authorization in the United States or European Union, or endorsement by the Medical Device Authority.
About TheraMod™
TheraMod (M) Sdn. Bhd. is a company that designs, develops, and manufactures professional rehabilitation systems. Its equipment is built for spine, joint, chiropractic, physiotherapy, and musculoskeletal care settings. Manufacturing is.
The current device portfolio is RxDecom®, Spinercise®, and FD-3000™. RxDecom® and FD-3000™ are registered Class A medical devices. Spinercise® is registered under number GA5390526-240502. Earlier stage programs are kept separate from registered devices in our own document control, so that a registered product is never presented as a concept and a concept is never presented as a registered product.
TheraMod is registered with the Medical Device Authority (MDA)’s Medical Device Authority, holds a manufacturer establishment licence, and operates an ISO 13485 certified quality management system. Alongside the equipment itself, we provide installation, operator training, documentation, service planning, and distributor support. You can read the full company profile on the About TheraMod page.
Frequently Asked Questions
What is RxDecom®?
Who is RxDecom® supplied to?
What distraction force does RxDecom® apply?
What distraction angles are available?
What patient size does RxDecom® accommodate?
Is RxDecom® registered with the Medical Device Authority?
Is TheraMod ISO 13485 certified?
What harness sizes are supplied with RxDecom®?
What does the split-bed function do?
How is RxDecom® controlled during a session?
How far does the table move?
Can RxDecom® be used with other TheraMod devices?
Does TheraMod provide installation, training, and service?
How do I request specifications or a quotation?
Where is the registered intended use statement for RxDecom®?
Related Pages
- Spinal decompression therapy equipment. What the equipment category is and what the evidence says.
- Spinal traction compared with decompression. How the two equipment categories differ.
- Professional use information. Who the equipment is for, and the training that comes with it.
- Rehabilitation device portfolio. All three registered devices in one place.
- FD-3000™ flexion distraction table. The second registered device in the portfolio.
- Spinercise®. Guided movement rehabilitation equipment.
- Distributor information. How TheraMod works with distributors and healthcare groups.
- Contact TheraMod. Request specifications, installation requirements, and training details.
Author Information
Yama Zafer, D.C., author of “RxDecom Controlled Spinal Distraction Device | HCP,” is the Founder and Managing Director of TheraMod (M) Sdn. Bhd. You can read his TheraMod™ corporate biography.
This page was reviewed and updated on 2 September 2026 against the current registration certificate, manufacturer establishment licence, and ISO 13485 certificates held by TheraMod (M) Sdn. Bhd.
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