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Ekso Bionics Plans 510(k) For Robotic Exoskeleton Based On FDA Class II Designation

The firm will submit a 510(k) later this month for its Ekso GT robotic skeleton, currently being marketed as a class I exempt device, based on feedback from FDA that robotic exoskeleton devices need to meet class II requirements.

Ekso Bionics Holdings Inc. can no longer rely on class I exempt status for its Ekso GT robotic exoskeleton. The company said Dec. 2 it plans to submit a 510(k) application later this month in response to FDA feedback.

Ekso GT is designed to help individuals with lower extremity weaknesses to stand up and walk. Ekso Bionics has been...

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