Dose
Record intensity, repetitions, duration, progression and missed sessions.
Real-work map · 10
Rehabilitation and assistance
Connect robotic dose, adaptation and assistance to active patient participation, therapist oversight and functional outcomes.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
10
FUURAA thesis
More repetitions are useful only when the delivered intervention is appropriate, tolerated and functionally meaningful.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Participation
Separate patient effort, device assistance, compensation and therapist input.
Function
Use validated outcomes tied to daily activity and participation.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Who is an appropriate patient?
- 02
Does assistance mask low effort?
- 03
How is fatigue or pain handled?
- 04
Does benefit persist outside sessions?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Patient-selection and dosing protocol
- 02
Evidence package 2
Assistance-effort and safety logs
- 03
Evidence package 3
Validated functional outcome series
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Kinematic improvement or session completion alone does not prove durable functional benefit.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
China NMPA · Published 2025-07-03
↗02Lifecycle regulation measures supporting high-end medical devices
Calls for classification guidance for surgical and rehabilitation robots, naming consensus, standards work and lifecycle regulatory support.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗03ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.
European Commission MDCG · MDCG 2020-1 · March 2020
↗Clinical evaluation and performance evaluation of medical device software
Connects valid clinical association, technical performance and clinical performance to a documented evaluation under the applicable regulation.