Merge Lancaster
Hosted by: The Candy Factory on Thursday, December 5th, 2024Featured Entrepreneur
Jake Henry
Founder of: Lectra Technologies
9 out of 10 people don’t finish rehab because traditional solutions are inconvenient, impersonal, and time-consuming, leading to extended recovery times and unresolved pain. Lectra solves this by integrating wireless muscle stimulation with kinesiology tape and a guided app experience, making rehab personalized, easy, and accessible anywhere. This combination reduces recovery time and improves outcomes for both chronic pain and post-injury rehabilitation.
Greatest Challenge:
One of Lectra’s biggest challenges is navigating the complex FDA clearance process for our innovative muscle stimulation device, which integrates kinesiology tape and Bluetooth-enabled electrodes. We've already consulted regulatory experts, initiated pre-submission research, and secured a seed grant to develop a robust 510(k) submission package. However, we need additional guidance and feedback on ensuring a streamlined process and identifying potential pitfalls as we aim for Class II device clearance.
