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Continue shoppingFORTHiQ FDA Clearance & Product Safety FAQ
Learn how FORTHiQ ensures the safety and quality of every device. We design all our wellness products to meet international health and safety standards.
Is the FORTHiQ Knee Massager FDA Cleared?
Yes. The FORTHiQ Knee Massager is FDA-registered as a Class II medical device under therapeutic heating and vibration therapy categories.
This means it meets FDA requirements for safety, labeling, and performance for home use.
What does FDA clearance mean?
FDA clearance confirms that the device has been reviewed and found substantially equivalent to other legally marketed therapeutic devices.
It ensures that the product is safe when used as directed and performs as intended.
Which FORTHiQ products are FDA cleared or registered?
The following devices are FDA-registered wellness products designed for at-home use:
FORTHiQ Knee Brace Massager Red+
FORTHiQ Knee Massager Smart Heat
Each model uses low-level heat, vibration, and red-light therapy consistent with FDA-recognized therapeutic modalities.
Are FORTHiQ devices safe for daily use?
Yes. All FORTHiQ devices undergo internal quality testing and comply with U.S. and international safety standards.
Follow the user manual and recommended session times to ensure optimal results.
Stop use if you experience skin irritation, discomfort, or unusual heat.
Does FDA clearance mean the device is approved for all medical conditions?
No. FDA clearance confirms the device’s safety and performance within its intended use (e.g., relaxation, pain relief, improved circulation).
It is not a cure or treatment for medical diseases. Always consult your healthcare provider for medical conditions.
Where can I learn more about FORTHiQ’s medical device certifications?
You can review device registration details and compliance documentation on our Product Safety & Certifications page or request verification through Customer Support