Cleared Special

L300 Go System (K190285) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190285 · Bioness, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
31d
Days
Class 2
Risk

K190285 is an FDA 510(k) clearance for the L300 Go System. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioness, Inc. devices

Submission Details

510(k) Number K190285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date March 14, 2019
Days to Decision 31 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 148d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 17
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K190285.
Nerve and Muscle Stimulator
K193276 · Shenzhen Xft Medical Limited · Sep 2020
L100 Go System
K200262 · Bioness, Inc. · Mar 2020
L360 Thigh System
K191587 · Bioness, Inc. · Sep 2019
L300 Go System
K173682 · Bioness, Inc. · Mar 2018
ODFS Pace XL
K171396 · Odstock Medical, Ltd. · Jan 2018
ROCHE COBAS ARGOS 5 DIFF
K912615 · Roche Diagnostic Systems, Inc. · Sep 1991