FDA.reportPublic FDA data

BIONESS MEDICAL, INC.

Matched from indexed company URL: Bioness, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30364717063036471706BIONESS MEDICAL, INC.1N2026-01-0125103 Rye Cyn Loop Valencia CA US 91355
30045538663004553866BIONESS INC.1Y2020-04-2525103 RYE CANYON LOOP Valencia CA US 91355

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810188050120L300 Go System - L300 Go System, Left Thigh Plus+1(800)211-9136info@bionessmedical.com
00810188050175L100 Go System - L100 Go System, Left+1(800)211-9136info@bionessmedical.com
00810188050274L300 Go System - Quick Fit Electrode, Right+1(800)211-9136info@bionessmedical.com
00810188050441H200 Wireless System - Cloth Electrodes Set+1(800)211-9136info@bionessmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
637211938235300K200262L100 Go SystemGZI2020-03-04
3348232049116425K200262L100 Go SystemGZI2020-03-04
3348231285664496K191587L360 Thigh SystemGZI2019-09-12
637211576712961K191587L360 Thigh SystemGZI2019-09-12
3348231578081126K190285L300 Go SystemGZI2019-03-14
637211779888258K190285L300 Go SystemGZI2019-03-14
637211081404928K173682L300 Go SystemGZI2018-03-09
3348231234362968K173682L300 Go SystemGZI2018-03-09
3348231359722825K162407L300 Go SystemGZI2017-01-27
637211786799224K162407L300 Go SystemGZI2017-01-27
637211056301811K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitGZF2015-02-20
637211076305888K123636H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICEGZI2013-05-01
637211997768273K122784NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHTGZI2012-12-27
637211011415854K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITGZI2011-09-15
3348232068002088K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITGZI2011-09-15
637211498599910K103343L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)GZI2011-04-29
637212033914153K080219MODIFICATION TO:NESS L300GZI2008-02-28
637212006279205K053468NESS L300GZI2006-07-07
3348231476380430DEN200050Portable Neuromodulation Stimulator (PoNS)QCF2021-03-26
637211361401176
637212001069087
3348231043392704
3348231198246189
3348231301541462
3348231598231856
3348231631087195

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZI172020-03-04
QCF12021-03-26
GZF12015-02-20

PMN#

GUDID#

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