FDA 510(k), K190285, L300 Go System

510(K) Number: K190285
Device Name: L300 Go System
Manufacturer: Bioness Inc.
Device Classification Name: Stimulator, Neuromuscular, External Functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 02/11/2019
Decision Date: 03/14/2019
Regulation Medical Specialty: Neurology

357 pages (834 of 1,191 original pages are fully redacted)