![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Acceleration Therapeutics' AT-101 Reclassified by FDA
Acceleration Therapeutics' AT-101 Reclassified by FDA
Acceleration Therapeutics Division of Non-Invasive Monitoring Systems announced that the FDA reclassified the flagship product of the company, the AT-101 device, from its listed FDA Class 1 (exempt) powered exercise device to a therapeutic vibrator requiring 510(k) submission.
Yahoo News (http://biz.yahoo.com/bw/050124/245445_1.html)
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
18Jul
-
21Oct