FDA Clears Cutera truFlex® for Muscle Rehab, Recovery, and Post-Surgical Use

Cutera, Inc. has announced that its truFlex® muscle stimulation system has received expanded US Food and Drug Administration (FDA) clearances for use in rehabilitation, recovery, and muscle wellness applications. Originally cleared for aesthetic body contouring, the system can now be used to strengthen and re-educate muscles, manage muscle spasms, and support post-surgical recovery—marking a notable shift into therapeutic indications.

The expanded FDA indications now include the strengthening, toning, and firming of muscles in the arms and calves; relaxation of muscle spasms; prevention of disuse atrophy; improvement of local circulation; maintenance or increase of range of motion; and post-operative calf muscle stimulation to prevent venous thrombosis. Additional uses include stimulation of neuromuscular tissue for bulk excitation in rehabilitative settings and adjunctive therapy for medically supervised conditions.

TruFlex employs proprietary Multi-Directional Stimulation (MDS) technology to deliver targeted muscle contractions through customizable applicators. Introduced in 2019, the platform was designed to address aesthetic goals via non-invasive muscle activation. With this new clearance, its utility expands significantly into functional medicine and physical rehabilitation.

“These new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength,” said Edward Alvarez, DDS, CEO of Restimulate Health. “Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey.”

“Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today,” added Taylor Harris, CEO of Cutera. “By extending truFlex’s uses into rehabilitation and recovery, we are opening new opportunities for providers to support patients across a broader spectrum of care.”

Cutera, Inc. has announced that its truFlex® muscle stimulation system has received expanded US Food and Drug Administration (FDA) clearances for use in rehabilitation, recovery, and muscle wellness applications. Originally cleared for aesthetic body contouring, the system can now be used to strengthen and re-educate muscles, manage muscle spasms, and support post-surgical recovery—marking a notable shift into therapeutic indications.

The expanded FDA indications now include the strengthening, toning, and firming of muscles in the arms and calves; relaxation of muscle spasms; prevention of disuse atrophy; improvement of local circulation; maintenance or increase of range of motion; and post-operative calf muscle stimulation to prevent venous thrombosis. Additional uses include stimulation of neuromuscular tissue for bulk excitation in rehabilitative settings and adjunctive therapy for medically supervised conditions.

TruFlex employs proprietary Multi-Directional Stimulation (MDS) technology to deliver targeted muscle contractions through customizable applicators. Introduced in 2019, the platform was designed to address aesthetic goals via non-invasive muscle activation. With this new clearance, its utility expands significantly into functional medicine and physical rehabilitation.

“These new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength,” said Edward Alvarez, DDS, CEO of Restimulate Health. “Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey.”

“Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today,” added Taylor Harris, CEO of Cutera. “By extending truFlex’s uses into rehabilitation and recovery, we are opening new opportunities for providers to support patients across a broader spectrum of care.”