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What are my limitations during the Stage I trial?

Answer

The external leads, bandage, and external stimulator are not waterproof. This precludes taking a shower during the Stage I trial. Also, the percutaneous leads are susceptible to migration. This risk is mitigated by avoiding activities such as reaching, lifting and bending.

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DISCLAIMER

Wavegate's EllipseTM platform with Active LoopTM technology has not yet been evaluated by the U.S. Food and Drug Administration and is not currently available for sale in the United States.

© 2026 by WAVEGATE CORPORATION

Ellipse, StimuLux, and Active Loop are trademarks of Wavegate Corporation

Ellipse platform technology is covered by multiple US and International issued patents and patents pending.

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