---
title: "Regulatory | Lionheart Longevity Investor Relations"
description: "Lionheart Health regulatory position: FDA 510(k) clearances, IRB-approved research and commercialization strategy."
url: https://investors.lionheartlongevity.com/science/regulatory
---

Science

# Regulatory Position & Clinical Development

Lionheart Health is developing additional applications of the Lionheart 240 Stimulus through its IRB-approved Lionheart Klotho Wellness Protocol, covering muscle, brain, immune, gut, vision, sexual vitality, joint, skin and hair/scalp wellness. The protocol combines bioelectric stimulation with diet, exercise, supplements and other specified modalities to evaluate safety and clinical outcomes.

The company’s regulatory strategy builds on the Sys\*Stim 240 platform’s FDA 510(k) clearance, K113017\. Lionheart’s research explores whether the cleared physiological effects, within multimodal protocols, can support additional wellness and therapeutic outcomes.

The company relies on the FDA-cleared indication of improving local circulation as a cornerstone for improvements in wellness of specific target organs. Muscle recovery is also a major contributor for specific organs targeted for wellness improvement, including muscles surrounding joints, facial cheek muscles, hair scalp muscles and within sexual organs, including improvements of range of motion of those target muscles.

Research oversight

The company reports that FDA has concurred with a nonsignificant-risk determination for the covered investigations, permitting research under IRB oversight and applicable abbreviated Investigational Device Exemption requirements. This research framework supports evidence generation for potential additional indications.

[Klotho-Up study design →](https://investors.lionheartlongevity.com/science/klotho-up-study)

## Cleared devices in the Lionheart platform

FDA 510(k) K113017

### Lionheart 240 Stimulus (Sys\*Stim 240 platform)

Includes increasing local blood circulation and, for specified waveform ranges, muscle re-education, prevention or retardation of disuse atrophy, maintenance or improvement of range of motion, and pain indications including arthritis and other inflammatory related pain.

FDA 510(k) K181955

### Wiemspro EMS suit with the BodStim™ protocol program

Cleared for augmenting health benefits of exercise and building muscle in healthy subjects.

FDA cleared

### Saebo stimulator (distributed by Lionheart Health)

Cleared for stroke recovery in addition to improving local circulation, pain and muscle recovery.

FDA 510(k) K141342

### AxioBionics stimulators (distributed by Lionheart Health)

Cleared indications matching the 240.

### Stimulation applications expressly listed in K141342

* TENS for pain relief (including inflammation as well as arthritis-related pain and also itchy sore tissues)
* Relaxation of muscle spasms
* Prevention or retardation of disuse atrophy
* Increasing local blood circulation (covering a broad range of applications)
* Muscle re-education
* Maintaining or increasing range of motion
* Immediate postoperative calf stimulation to prevent venous thrombosis
* Functional electrical stimulation (covering a broad range of applications)

## Commercialization strategy

Lionheart’s commercialization strategy is to maintain claims within applicable regulatory requirements, assess general-wellness eligibility for each specific product and use, and pursue additional FDA authorization where required. Clinical data will inform future submissions, with regulatory requirements, timing and outcomes remaining subject to FDA review.

Due diligence

FDA clearance letters, IRB documents, the investigators list, the regulatory compliance dashboard and SOPs are available as PDFs.

[ View documents](https://investors.lionheartlongevity.com/resources/documents#regulatory)

Disclosure

The existing clearance does not establish FDA authorization for every application being studied. IRB approval and FDA’s nonsignificant-risk determination concern the investigations; they do not constitute commercial clearance, approval of the Klotho Wellness Protocol, or confirmation of efficacy for the additional outcomes.