
Regulatory Insight, Inc.
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EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS is an FDA 510(k)-cleared medical device (K020094) manufactured by Regulatory Insight, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 7, 2002. Regulation: 8.