Product Code: GWN
FDA class 2
21 CFR 882.1460
Nystagmograph
Neurology
The Nystagmograph is a neurological diagnostic device used to detect, record, and analyze nystagmus (involuntary eye movements) to evaluate vestibular and central nervous system function, aiding in the diagnosis of disorders affecting balance and coordination. It is classified as FDA Class 2, presenting moderate risk and requiring 510(k) premarket clearance. The product code is GWN, regulated under 21 CFR 882.1460 in the Neurology specialty. This device is eligible for third-party 510(k) review.
510(k)s
59
FEI Numbers
15
Registration Numbers
15
Unique Applicants
43
Years Active
44
Basic Information
- Product Code
- GWN
- Device Class
- FDA class 2
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 59 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243709 | NeuroEars-Anna | Aug 25, 2025 | Substantially Equivalent | Neuroears, Inc. |
| K242198 | ICS Dizcovery (1091) | Feb 14, 2025 | Substantially Equivalent | Natus Medical Denmark Aps |
| K242726 | Synapsys VHIT | Jan 03, 2025 | Substantially Equivalent | Inventis S.R.L. |
| K223047 | NeuroSwift Pro | Jun 29, 2023 | Substantially Equivalent | Neurobit Technologies Co., Ltd. |
| K203082 | Insight Infrared Video Goggles | Nov 12, 2020 | Substantially Equivalent | Vestibular First |
| K200534 | VisualEyes | Aug 12, 2020 | Substantially Equivalent | Interacoustics A/S |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Nov 29, 2019 | Substantially Equivalent | Neurolign USA, LLC |
| K181771 | RightEye Vision System | Sep 28, 2018 | Substantially Equivalent | Righteye, LLC |
| K182214 | DizzyDoctor System 1.0.0 | Sep 14, 2018 | Substantially Equivalent | Dizzydoctor Systems, LLC |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Jul 24, 2018 | Substantially Equivalent | Neuro Kinetics, Inc. |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Nov 22, 2017 | Substantially Equivalent | Neuro Kinetics, Inc. |
| K163270 | ISEN-Goggles with Data Viewer | Sep 25, 2017 | Substantially Equivalent | Isent Tech & Trading Company, Ltd. |
| K163149 | VisualEyes | Apr 26, 2017 | Substantially Equivalent | Interacoustics A/S |
| K163558 | Synapsys Ulmer Video Nystagmograph | Mar 23, 2017 | Substantially Equivalent | Synapsys SA |
| K152727 | ISEN-Goggles | Apr 26, 2016 | Substantially Equivalent | Isen Tech & Trading Company, Ltd. |
| K152915 | EYE-SYNC | Jan 29, 2016 | Substantially Equivalent | Syncthink, Inc. |
| K152112 | VisualEyes | Dec 29, 2015 | Substantially Equivalent | Interacoustics A/S |
| K151504 | ICS Impulse | Nov 16, 2015 | Substantially Equivalent | Gn Otometrics |
| K143607 | I-Portal NOTC, VNG and VOG | Jul 08, 2015 | Substantially Equivalent | Neuro Kinetics, Inc. |
| K131681 | EYESEECAM VHIT | Sep 06, 2013 | Substantially Equivalent | Interacoustics A/S |
| K130201 | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM | Apr 26, 2013 | Substantially Equivalent | Ototronix, LLC |
| K122550 | ICS IMPULSE | Feb 01, 2013 | Substantially Equivalent | Gn Otometrics |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | Aug 06, 2009 | Substantially Equivalent | Neuro Kinetics |
| K072254 | VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM | Feb 05, 2008 | Substantially Equivalent | Interacoustics A/S |
| K070670 | EYETRACKER/IDEAS | Sep 18, 2007 | Substantially Equivalent | S.A. Instrumentation Difra |
| K070729 | BALANCEBACK MOBILE INTUITIVE VNG SYSTEM | Mar 30, 2007 | Substantially Equivalent | Fall Prevention Technologies, LLC |
| K062015 | CHRONOS VISION EYE TRACKING DEVICE (C-ETD) | Oct 31, 2006 | Substantially Equivalent | Chronos Vision |
| K061791 | FOCUS VNG/ENG TYPE 1068 | Jul 11, 2006 | Substantially Equivalent | Gn Otometrics A/S |
| K050098 | DDAT OMT | May 23, 2005 | Substantially Equivalent | Ddat(Uk), Ltd. |
| K042529 | BALANCEBACK VNG SYSTEM | Oct 06, 2004 | Substantially Equivalent | Fall Prevention Technologies, LLC |
| K013060 | ICS MEDICAL MODEL VG-30 VIDEO GOGGLES | Dec 10, 2001 | Substantially Equivalent | Ics Medical |
| K010059 | ENGPLUS | Feb 27, 2001 | Substantially Equivalent | Western Systems Research, Inc. |
| K003644 | EYETECT TREMOR MONITOR UNIT (TMU) | Feb 01, 2001 | Substantially Equivalent | Eyetect, LLC |
| K992473 | EXPRESSEYE | Aug 12, 1999 | Substantially Equivalent | Optomotor Laboratories |
| K991642 | EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX | Aug 03, 1999 | Substantially Equivalent | Bertec Corp. |
| K991497 | ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM | Jul 28, 1999 | Substantially Equivalent | Ics Medical Corp. |
| K982103 | ULMER (VNG) VIDEO NYSTAGMOGRAPH | Sep 11, 1998 | Substantially Equivalent | Synapsys, Inc. |
| K972631 | ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER | Sep 22, 1997 | Substantially Equivalent | Ics Medical Corp. |
| K972243 | 2D VOG - VIDEO-OCULOGRAPHY | Sep 10, 1997 | Substantially Equivalent | Sensomotoric Instruments, GmbH |
| K964646 | VIDEO EYE TRAKKER | Jul 15, 1997 | Substantially Equivalent | Micromedical Technologies, Inc. |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | Jul 15, 1997 | Substantially Equivalent | Micromedical Technologies, Inc. |
| K941928 | VARIOUS ELECTRODES | Feb 03, 1995 | Substantially Equivalent | Bio-Logic Systems Corp. |
| K926312 | INFRARED EYE MOVEMENT MONITOR | Dec 15, 1994 | Substantially Equivalent | Microguide, Inc. |
| K925111 | HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM | Mar 23, 1994 | Substantially Equivalent | Eye Dynamics, Inc. |
| K904385 | JANUS ATAC ENG ANALYSIS SYSTEM | Jun 10, 1992 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K884294 | NICOLET NYSTAR PLUS SYSTEM | Nov 23, 1988 | Substantially Equivalent | Nicolet Instrument Corp. |
| K871466 | VESTIBULAR AUTOROTATION TEST | Jul 24, 1987 | Substantially Equivalent | Western Systems Research, Inc. |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | Mar 23, 1987 | Substantially Equivalent | Micromedical Technologies, Inc. |
| K860457 | ELECTROCARDIOGRAPH CONTINUOUS MONITOR | Apr 30, 1986 | Substantially Equivalent | Oxford Medilog, Inc. |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | Nov 27, 1985 | Substantially Equivalent | Nicolet Biomedical Instruments |
| K850180 | ELECTRONYSTAGMOGRAPH (ENG RECORDER) | Jul 22, 1985 | Substantially Equivalent | Bio-Logic Systems Corp. |
| K842886 | TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL | Dec 12, 1984 | Substantially Equivalent | Teca, Inc. |
| K843004 | SERVO MED NYSTAGMOGRAPH NG-1 | Oct 30, 1984 | Substantially Equivalent | Servo Med, Inc. |
| K834148 | PHILLY BOLTS | Feb 10, 1984 | Substantially Equivalent | Philadelphia Medical Specialties |
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Jan 28, 1983 | Substantially Equivalent | Kelleher Corp. |
| K823459 | PHILLY BOLT ADULT PROCEDURE KIT | Dec 22, 1982 | Substantially Equivalent | Philadelphia Medical Specialties |
| K822266 | NAGASHIMA KN-52 SACCADE & PURSUIT STIM | Aug 16, 1982 | Substantially Equivalent | Kelleher Corp. |
| K820151 | PHILLY INFANT BOLT | Jan 28, 1982 | Substantially Equivalent | Philadelphia Medical Specialties |
| K812180 | LIFE-TECH #5102 VISULAB | Aug 21, 1981 | Substantially Equivalent | Life-Tech Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.