Medical Device and Rehabilitation Technology Manufacturer
Key Takeaways About TheraMod
| Area | Summary |
|---|---|
| Company | Medical device and rehabilitation technology company |
| Primary Focus | Development, manufacturing, quality management, training, and support for professional rehabilitation technologies |
| Current Commercial Platforms | RxDecom®, Spinercise® and FD-3000™ (all registered Class A) |
| Professional Settings | Designed for use by appropriately trained healthcare professionals in professional rehabilitation environments |
| Quality Foundation | ISO 13485-certified quality management system supporting design, development, and manufacturing activities |
| Regulatory Status | Manufacturer establishment licence and registered products where applicable; product status is presented according to current regulatory documentation |
| Clinical Areas | Spine, musculoskeletal, rehabilitation, movement, and functional recovery applications |
| Growth Strategy | Controlled manufacturing expansion, distributor development, clinical evidence generation, and phased international commercialization |
| Company Vision | To develop professional rehabilitation technologies supported by quality systems, responsible evidence development, and long-term innovation |
Current Corporate and Regulatory Foundation
TheraMod holds manufacturer establishment licence MDA-5532-K124, valid from 5 March 2024 to 4 March 2027. Its ISO 13485 quality-management-system certificates include Q2MYS 080272 0004 Rev. 00, valid to 5 November 2027, and Q5 080272 0003 Rev. 02 in Germany, valid to 18 February 2028.
RxDecom®, Spinercise® and FD-3000™ are registered Class A medical devices. Registration and certification are stated as regulatory and quality-system facts; they do not establish clinical outcomes, superiority, foreign-market authorization, or MDA/KKM endorsement.
About TheraMod Medical Device Company
TheraMod develops rehabilitation equipment for trained clinical environments where workflow, positioning, documentation, servicing, and training matter.
Our current product categories include:
- spinal decompression equipment,
- movement rehabilitation equipment,
- flexion-distraction rehabilitation equipment.
This broader structure gives TheraMod a stronger commercial foundation than a single-device company.
For clinics, distributors, and investors, the homepage provides an overview of our current devices, manufacturing direction, quality-system structure, and future growth pathway.
Current Rehabilitation Devices
TheraMod’s current rehabilitation devices include RxDecom®, Spinercise®, and FD-3000™.
RxDecom®
RxDecom® is TheraMod’s spinal decompression machine developed for trained rehabilitation environments where positioning, guided workflow, load measurement, and table access are important.
Spinercise®
Spinercise® is TheraMod’s movement rehabilitation device for guided movement and structured musculoskeletal rehabilitation workflows.
FD-3000™
FD-3000™ is TheraMod’s flexion-distraction rehabilitation device developed for table-assisted positioning and structured rehabilitation environments.
TheraMod develops rehabilitation devices for trained professional environments.
Manufacturing, Licensing, and Quality Systems
Medical device manufacturing requires more than product concepts. It also depends on production systems, quality controls, technical records, servicing pathways, training materials, and market-specific regulatory preparation.
We are registered with the Medical Device Authority (MDA) and hold a medical device manufacturing licence. We operate under an ISO 13485-certified quality management system certified by TÜV SÜD.
TheraMod publishes licence numbers, certificate references, and verification links where available.
Regulatory record
- Establishment licence
- MDA-5532-K124
- Licence validity
- 05 Mar 2024 to 04 Mar 2027
- RxDecom®
- GA10689826-235584
- FD-3000™
- GA6416424-169842
- Spinercise®
- GA5390526-240502
- Quality system
- ISO 13485
Registration and certification are regulatory and quality-system facts. They do not establish clinical outcomes, comparative superiority, authorization in another market, or MDA endorsement.
Manufacturing and Controlled Quality Release
TheraMod operates a controlled production model supported by documented manufacturing flow, incoming inspection, part traceability, in-process checks, functional testing, final inspection, and quality release.
Selected parts and processes may be supported by confidential external fabrication partners. TheraMod retains control of the master engineering files, complete product architecture, controlled bill of materials, revision history, final assembly, regulatory records, quality release, and customer relationships.
Medical Device Investment 2026
TheraMod is open to discussions with suitable investors, strategic partners, healthcare groups, manufacturers, and distributors.
Our next stage includes:
- Manufacturing growth,
- Distributor onboarding,
- Service planning,
- Technical training,
- Regulatory preparation,
- Product-line expansion,
- selected new markets.
Distributor Opportunities
TheraMod welcomes distributor discussions for rehabilitation equipment, servicing, maintenance planning, training systems, product education, and selected regional opportunities.
Distributor pathways should be reviewed market by market because regulatory, servicing, pricing, documentation, and training requirements may vary by country.
TheraMod builds a range of rehabilitation devices rather than a single product.
We have:
- Multiple rehabilitation equipment categories,
- A manufacturing pathway,
- Quality-system structure,
- Current devices,
- Future R&D direction,
- Distributor planning,
- Investor growth pathway.
This creates a broader commercial structure for long-term rehabilitation equipment development.
TheraMod operates a controlled production model supported by documented manufacturing flow, incoming inspection, part traceability, in-process checks, functional testing, final inspection, and quality release.
Selected parts and processes may be supported by confidential external fabrication partners. TheraMod retains control of the master engineering files, complete product architecture, controlled bill of materials, revision history, final assembly, regulatory records, quality release, and customer relationships.
Training, Service, and Distributor Support
Equipment supply is supported by structured implementation planning. TheraMod’s framework includes professional-user training, distributor onboarding, installation guidance, warranty documentation, maintenance planning, spare-parts readiness, technical escalation, and approved communication controls.
Distributor discussions are reviewed market by market because registration, import, training, service, documentation, pricing, and claims requirements differ by jurisdiction.
Investor and Strategic Partner Information
TheraMod is open to discussions with qualified investors, strategic partners, healthcare groups, manufacturers, and medical-device distributors whose experience is relevant to regulated manufacturing, evidence development, service-supported commercialization, and international market access.
Detailed financial projections, buyer-economics analyses, supplier evidence, and transaction materials are provided only through a controlled diligence process and are not presented as public guarantees.
Important Public Information
This website provides corporate information about TheraMod’s company activities and product range. Professional-use product information should be accessed only through the designated healthcare-professional area. Product availability, permitted claims, registration status, and supply terms remain subject to current records and jurisdiction-specific requirements.
Author
Yama Zafer, D.C., author of “Medical Device Manufacturer | TheraMod,” is the Founder and Managing Director of TheraMod (M) Sdn. Bhd.; read his TheraMod corporate biography.
Related Pages
Last Updated and Reviewed
“TheraMod Medical Device Manufacturer” was reviewed and updated on 1 September 2026 to reflect the current corporate, regulatory, quality-system, product-stage, and document-control information supplied for TheraMod.
Frequently Asked Questions
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What is Spinercise®?
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