Regulatory Insight, Inc. is one of 18961 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Regulatory Insight, Inc. - FDA 510(k) Cleared Devices
Recent clearances: KEGEL SMART, KEGELSMART PEARL, ETHEREA, 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
4
Total
4
Cleared
0
Denied
Regulatory Insight, Inc. has 4 FDA 510(k) cleared medical devices. Based in Littleton, US.
Historical record: 4 cleared submissions from 2002 to 2014. Primary specialty: Physical Medicine.
Browse the FDA 510(k) cleared devices submitted by Regulatory Insight, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Regulatory Insight, Inc.
4 devices
Cleared
Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
Gastroenterology & Urology
166d
Cleared
Apr 06, 2012
ETHEREA
General & Plastic Surgery
220d
Cleared
Mar 08, 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN...
Physical Medicine
56d
Cleared
Mar 08, 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL...
Physical Medicine
56d