Search Results
Found 1 results
510(k) Data Aggregation
K Number
K241488Device Name
TrainFES Advance
Manufacturer
Trainfes
Date Cleared
2025-02-05
(257 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Trainfes
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- increasing local blood circulation
- immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle re-education
As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
Device Description
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
Ask a Question
Page 1 of 1