L100 Go System
K-Number: K200262 · 2020-03-04
ApplicantBioness, Inc.
Decision Date2020-03-04
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
L100 Go System is a medical device manufactured by Bioness, Inc.. It received FDA 510(k) clearance on 2020-03-04 under approval number K200262. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the L100 Go System?
L100 Go System is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Bioness, Inc.. The 510(k) number is K200262.
When was L100 Go System approved by the FDA?
L100 Go System received FDA 510(k) clearance on 2020-03-04, under approval number K200262.
What company makes L100 Go System?
L100 Go System is manufactured by Bioness, Inc..
What is the FDA product code for L100 Go System?
The FDA product code for L100 Go System is GZI.
Other Devices by Bioness, Inc.
Related Devices (Code: GZI)
K153163ReGraspRehabtronics, Inc.
K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited
K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc.
K162470RT300 FES cycle ergometerRestorative Therapies, Inc.
K170132MyoCycle Home, MyoCycle ProMyolyn, LLC
K162683RehaStim 2Hasomed GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.