Intrumentation Difra

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the…

Registry build 21.09.26

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient’s head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Beijing (1).

Chinese manufacturers registered for FDA product code GWN
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

Regulatory record for Intrumentation Difra
Listed by Instrumentation Difra SA
FDA product code GWN
Device type Nystagmograph
Device class Class 2
Regulation 21 CFR 882.1460
510(k) K070670
Record published 2017-05-19
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Contains natural rubber latex
Label carries serial number

Catalogue Numbers

Catalogue numbers for Intrumentation Difra
Catalogue number Size Status
HeadStar In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer