Built on a disciplined development program.
Valdara is being developed through a structured clinical, engineering, quality, and regulatory program, with a development effort designed to support an FDA 510(k) submission for musculoskeletal therapeutic ultrasound.
The 510(k) pathway for musculoskeletal ultrasound devices
What is a 510(k)?
A regulatory pathway used by the FDA to evaluate whether a new medical device is substantially equivalent to an existing legally marketed device.
Why this pathway?
Therapeutic ultrasound and ultrasonic diathermy devices already have established regulatory classifications for deep heating of musculoskeletal tissues, such as pain relief, muscle spasm, joint contracture, and increased local circulation.
FDA 510(k) Pathway Overview
Valdara is currently in the verification & validation stage, prior to 510(k) submission.
A clear path from concept to submission
Valdara is being advanced along a defined development path, from identifying the clinical need to 510(k) submission and FDA review.
Valdara is currently progressing through the verification, validation, and safety-testing stages, with submission assembly planned following key electrical safety and EMC milestones.
Development Timeline
Clinical Need
CompleteIdentified target indication and patient population
Product Definition
CompleteDevice specifications and intended use established
Verification & Validation
Current StageActive V&V testing underway
Safety & EMC Testing
Electrical safety and electromagnetic compatibility
510(k) Submission
Assembly and filing with FDA
FDA Review
Substantial equivalence determination
Current status and future availability
Valdara is a medical device in development, has not been FDA cleared, and is not available for commercial sale. Final indications and specifications are subject to change during development and FDA review.
Regulatory FAQ
Developed to support future outpatient musculoskeletal care.
If you are evaluating Valdara for your musculoskeletal practice and would like to understand the development timeline and regulatory approach in more detail, we invite you to connect with our team.