ISEN-Goggles
ISEN-Goggles record and visually display eye movements, including nystagmus. The opaque goggles fit over the face with an adjustable elastic headband. Two internal video cameras capture the…
ISEN-Goggles record and visually display eye movements, including nystagmus. The opaque goggles fit over the face with an adjustable elastic headband. Two internal video cameras capture the eyes, with an image processor showing both views together on the attached LCD screen.
Eight infrared LEDs illuminate the eyes for the cameras, while two green LEDs provide optional visual fixation points. The infrared lights have a peak wavelength of 940 nm and the green lights 573 nm. Buttons on the goggle-mounted display control operation.
Listed Item
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles (“ISEN-Goggles”). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device’s function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device’s SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
Recording and Power
Video is stored in internal SD-type memory and can be transferred through a micro-USB port. An internal rechargeable lithium-ion battery powers the goggles. The assembly combines the cameras, illumination, display and recording storage in a wearable unit.
Who Else Makes It
Concentrated in Guangdong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Isen Tech.&Trading Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Isen Tech.&Trading Co., Ltd., China |
|---|---|
| FDA product code | GWN |
| Device type | Nystagmograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1460 |
| Establishment | Manufacturer |
| 510(k) | K152727 |
| Record published | 2017-09-01 |
| Record revised | 2026-07-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V06 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 17 |
| Interacoustics | Interacoustics A/S | 15 |
| VNG | Inventis SRL | 9 |
| Instrumentation Difra SA | Instrumentation Difra SA | 8 |
| Nystagmograph | Medtronic PS Medical | 7 |
| Instrumentation Difra | Instrumentation Difra SA | 7 |
| Otometrics | Natus Medical Denmark ApS | 5 |
| Vestibular First | Vestibular First | 4 |
| Micromedical Technologies | Micromedical Technologies, Inc. | 3 |
| Complete Monocular wireless Smart Cam system with Xpress mask | Synapsys SA | 2 |
| Synapsys Vhit | Inventis SRL | 2 |
| EYE-Sync | Neurosync, Inc. | 2 |
Showing 12 of 37. All products under Nystagmograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152727 | 2016-04-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.