Otometrics
1085 Face Cushion 2 (10 Boxes/100 Cushions)
3manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | GWN |
| Device type | Nystagmograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1460 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-11-20 |
| Record revised | 2025-11-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Carton of 12, carton of 10, carton box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1085, STRAP ASSEMBLY | In distribution | |
| 1085, FACE PAD ASSEMBLY KIT V2 | In distribution | |
| 1085, FACE CUSHION 2 ASM KIT | In distribution | |
| Goggle face cushion kit | In distribution | |
| 1085, Face Cushion 2 Box Kit | 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 |
| 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 |
| I-Portal Super VNG | N K I | 2 |
Showing 12 of 37. All products under Nystagmograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242198 | 2025-02-14 |
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.