Specialists in physical therapy and recovery devices
We focus on five device families. That focus means fewer surprises in testing, faster submissions and manufacturing processes already proven on similar products.
Start with the device family
Each family concentrates risk in a different place. Select one to see the engineering focus and the standards that usually shape the first test plan.
Spinal traction
Cervical and lumbar tables, controllers
Accurate force control and measurement, patient-release and emergency stop, motor safety
Full device-family comparison
Use this view when comparing product types or preparing an early supplier brief.
| Device family | Typical engineering challenges | Key standards we design to |
|---|---|---|
| Spinal traction Cervical and lumbar tables, controllers | Accurate force control and measurement, patient-release and emergency stop, motor safety | IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971 |
| Knee traction & rehab Distraction, CPM, rehab devices | Range-of-motion limits, joint alignment across patient sizes, repeatable load profiles | IEC 60601-1, IEC 62366-1, ISO 14971 |
| Pneumatic compression Sequential pumps and garments | Pressure accuracy per chamber, leak detection, over-pressure protection, garment durability | IEC 60601-1, IEC 60601-1-11, ISO 10993 for garments |
| Massage & non-pneumatic compression Percussive, vibration, mechanical | Vibration and noise, battery safety, handheld ergonomics, motor life | IEC 60601-1 or IEC 60335 as applicable, IEC 62133-2 for batteries |
| Thermal therapy Heat, cold and contrast | Surface temperature limits, independent thermal cut-offs, uniform heating | IEC 80601-2-35, IEC 60601-1-11 |
| Connected & wearable App-controlled and body-worn versions of the above | Battery life, Bluetooth reliability, cybersecurity, skin-contact materials, comfort | IEC 62304, IEC 81001-5-1, IEC 60601-1-11, ISO 10993 series, Radio approvals |
Your regulatory team should confirm the standards list for each device. Applicable standards depend on intended use and classification.
Clinical and home-use devices need different evidence
The same therapy can create different usability, durability and safety requirements depending on who operates the device and where.
Clinical devices
For chiropractors, physical therapists and clinics. Designed for continuous duty, cleaning between patients, and professional-use labeling.
Focus: duty cycle · cleaning · trained usersHome-use devices
For patients and athletes. Designed to IEC 60601-1-11 for the home environment, with lay-user usability validation.
Focus: lay users · portability · home conditionsBring us the device, use environment and intended market.
We will map the engineering risks, evidence path and manufacturing implications for your starting point.