FDA.reportPublic FDA data

BIONESS MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30364717063036471706BIONESS MEDICAL, INC.1N2026-01-0125103 Rye Cyn 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
00810188050014Vector Gait and Safety System - Vector Gait and Safety System, Elite Model+1(800)211-9136info@bionessmedical.com
00810188050021Bioness Integrated System (BITS) Bedside Configuration - "Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24"" Display with Software"+1(800)211-9136info@bionessmedical.com
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS Balance - BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit+1(800)211-9136info@bionessmedical.com
00810188050052L360 Thigh System - L360 Thigh System Kit, Right+1(800)211-9136info@bionessmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3348232049116425K200262L100 Go SystemGZI2020-03-04
3348231285664496K191587L360 Thigh SystemGZI2019-09-12
3348231578081126K190285L300 Go SystemGZI2019-03-14
3348231234362968K173682L300 Go SystemGZI2018-03-09
3348231359722825K162407L300 Go SystemGZI2017-01-27
3348232068002088K111767NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITGZI2011-09-15
3348231476380430DEN200050Portable Neuromodulation Stimulator (PoNS)QCF2021-03-26
3348231043392704
3348231198246189
3348231301541462
3348231598231856
3348231631087195

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZI62020-03-04
QCF12021-03-26

GUDID#

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