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Acceleration Therapeutics' AT-101 reclassified by the FDA

This article was originally published in Clinica

Executive Summary

The US FDA has asked Acceleration Therapeutics to reclassify its power exercise device, AT-101, following the discovery that it no longer meets FDA class 1 (exempt) requirements. The company said the matter was of serious concern to its business and is unable to resume selling the product, a full body vibrating mattress, until it receives a 510(k) allowance letter from the FDA.

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