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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 marketing it as a low-risk, class I device, but FDA...

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