Tibion Receives TÜV Certification for PK100 Bionic Leg Orthosis

Tibion, a provider of bionic devices for rehabilitation and mobility, announced today it has received TÜV certification for its PK100 Bionic Leg Orthosis. The Tibion PK100 product has been tested and evaluated for compliance with internationally recognized standards for the safety of medical products. Compliance to the standards has resulted in NRTL (Nationally Recognized Testing Laboratory) and SCC (Standards Council of Canada) certification for the U.S. and Canada from TÜV Rheinland of North America.

Tibion’s PK100 Bionic Leg Orthosis is a wearable device for the leg which actively and transparently supplements muscle strength to enhance rehabilitation therapy and provide mobility assistance for those patients with loss of muscle function. Patients with neuromuscular impairment due to stroke or chronic disease may benefit from this technology. The PK100 uses sensors to automatically detect the user’s actions, such as sitting/standing, walking, and ascending/descending stairs which allow it to transparently apply the force needed to augment the user’s actions.

“At Tibion, we are committed to providing high quality products to assist clinicians and their patients who are dealing with loss of muscle function,” said Kern Bhugra, Tibion President and Cofounder. “This TÜV certification provides the highest assurance that the PK100 Bionic Leg Orthosis will perform in a safe manner for its intended use as a medical product for rehabilitation and mobility enhancement.”

About TÜV Rheinland of North America
As an NRTL for the United States and an SCC accredited Certification Body for Canada, TÜV Rheinland of North America delivers premier independent testing, assessment, and certification services for medical products helping manufacturers demonstrate compliance to international standards. TÜV Rheinland of North America is a subsidiary of TÜV Rheinland Group of Cologne, Germany, which has over 130 years of product testing and certification experience and offices in over 40 countries worldwide.

About Tibion
Tibion is a privately held company located at NASA Research Park, Moffett Field, California. The company’s mission is to develop smart medical devices and therapies that address the needs of neuromuscular and musculoskeletal deficiencies. Tibion’s products are enabled by patented innovations encompassing a broad range of disciplines, including orthotics, biomechanics, robotics, and embedded control systems. The company’s PK100 Bionic Leg Orthosis is a wearable, noninvasive bionic device for the leg to enhance rehabilitation and help patients improve muscle function as well as to provide assistance with activities of daily living.