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FDA Disclosure

Understanding the Regulatory Position of Tennant Technology

This disclosure explains how Tennant Health describes its technologies, intended uses and educational materials in relation to applicable regulatory terminology and general-wellness positioning.

Regulatory Information Intended Use Consumer Clarity
Effective Date: May 20, 2026

Tennant Health is not the U.S. Food and Drug Administration and does not speak on behalf of the FDA.

Our Regulatory Position

Two Technologies. Different Regulatory Positions.

The Tennant BioTransducer® and Tennant BioModulator® serve different roles within the Tennant System. Their intended uses and regulatory positions should be understood separately.

General-Wellness Technology

Tennant BioTransducer®

The BioTransducer® is presented as a contact-free general-wellness technology used within the Tennant System and Dr. Jerry Tennant’s Healing Is Voltage® educational framework.

General-Wellness Purpose

Presented to support overall wellness concepts rather than medical diagnosis or disease treatment.

Contact-Free Technology

Designed to operate without direct electrical stimulation or physical contact with the skin.

Framework-Based Education

Described within the Tennant framework as supporting polarity, energetic balance and whole-body wellness.

Regulatory Boundary

The BioTransducer® is not represented as diagnosing, treating, curing, mitigating or preventing disease.

FDA-Accepted Class II Device

Tennant BioModulator®

FDA-Accepted for Its Applicable Pain-Relief Use

The Tennant BioModulator® is an FDA-accepted Class II transcutaneous electrostimulator intended for its applicable pain-relief use. Authorization from a licensed healthcare provider is required.

FDA-Accepted Classification

Classified as a Class II transcutaneous electrostimulator within the applicable medical-device framework.

Applicable Pain-Relief Use

Its regulated medical-device positioning applies to the pain-relief use supported by its current documentation.

Licensed-Provider Authorization

Authorization may be completed through an independent licensed healthcare provider or qualification service where applicable.

Regulatory Boundary

FDA acceptance and Class II classification do not authorize claims beyond the BioModulator®’s applicable intended use.

Always review the current intended-use information, product instructions, warnings, precautions and contraindications supplied with the applicable Tennant technology.

Intended Use and Product Information

How to Understand Our Product Information

The BioTransducer®, BioModulator® and Healing Is Voltage® educational framework each have a distinct role. Explore the categories below to understand what applies to each technology and how Tennant Health presents that information.

Contact-Free General-Wellness Technology

Understanding the BioTransducer®

The BioTransducer® is presented as contact-free technology intended to support general wellness. Information about the BioTransducer® should be understood within that general-wellness position.

Designed for contact-free use

Presented for general-wellness support

May be incorporated into personal wellness routines

Described through non-diagnostic wellness information

Supported by product-specific instructions and education

Distinct from the BioModulator® regulatory position

What this means for consumers

The BioTransducer® is not represented as diagnosing, treating, curing, mitigating or preventing any disease or medical condition. General-wellness information should not be interpreted as a medical claim or a substitute for professional care.

Experience, Evidence and Continued Discovery

From Individual Experience to Meaningful Research

Many people discover Tennant Health while searching for additional support with serious, persistent or complex health challenges. Their experiences matter—and they can also help identify important questions that deserve careful scientific investigation.

Why Continued Research Matters

Meaningful observations can become the beginning of better evidence.

Tennant Health has heard from individuals who describe significant changes in their health and quality of life after incorporating Tennant technologies into their broader wellness journey. These experiences are important, but an individual result is not the same as a controlled clinical study or an FDA-accepted indication.

Rather than dismissing promising observations—or presenting them as settled clinical proof—Tennant Health believes they should help guide responsible documentation, thoughtful inquiry and future research.

Explore the Evidence Path

Different kinds of information answer different questions.

Select each category to understand how Tennant Health distinguishes personal experience, educational theory and formal research.

Individual Outcomes

Personal experiences can reveal important possibilities.

People come to Tennant Health with different histories, healthcare needs, lifestyles and goals. Some report meaningful changes after incorporating Tennant technologies into a broader plan of support. Their experiences deserve to be heard and documented carefully.

An individual account describes that person’s experience.

Results can vary substantially from one person to another.

Other therapies or lifestyle factors may contribute to an outcome.

A personal outcome can identify a question worthy of study.

Important distinction

A testimonial or individual outcome is not proof that a product will produce the same result for another person, and it does not establish a new FDA-accepted use.

Informed and Responsible Use

Understand the Technology Before You Begin

Tennant Health provides product-specific guidance to help people understand the differences between the technologies, applicable authorization requirements and important safety considerations.

General-Wellness Technology

BioTransducer®

The BioTransducer® is contact-free technology presented for general-wellness use. Owners should follow the current instructions, education and safety information supplied with the technology.

Contact-free operation

General-wellness positioning

Product-specific owner education

FDA-Accepted Pain-Relief Use

BioModulator®

The BioModulator® is an FDA-accepted Class II transcutaneous electrostimulator intended for its applicable pain-relief use. It requires authorization from a licensed healthcare provider.

Contact-applied bioadaptive microcurrent

Applicable pain-relief use

Licensed provider authorization required

Before and During Use

Essential guidance for informed decisions

Open each topic for additional information about authorization, instructions, contraindications and professional care.

Authorization provides an opportunity for a licensed healthcare provider to review relevant health information before the BioModulator® is provided. Authorization is not a guarantee that the technology is appropriate for every individual or every health concern.

Seek immediate care when needed.

Tennant technologies are not emergency services. If you believe you may be experiencing a medical emergency, call 911 or seek immediate medical assistance.

FDA Disclosure Questions

Frequently Asked Questions

Clear answers about the regulatory position, intended use and responsible use of Tennant technologies.

The Tennant BioModulator® is an FDA-accepted Class II transcutaneous electrostimulator intended for its applicable pain-relief use. This status applies specifically to the BioModulator® and does not expand its intended use to the diagnosis, treatment or cure of unrelated diseases.

Clarity without dismissing possibility

Tennant Health is committed to communicating current regulatory information clearly while continuing to listen, document, educate and support responsible scientific investigation.