Diopsys®
Disposable Hypoallergenic EEG Electrodes, Pouch/100
1manufacturer
13catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | Diopsys Inc., United States |
|---|---|
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K101763 |
| Record published | 2017-03-27 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6020-0001-00 | In distribution | |
| 6020-0002-00 | In distribution | |
| 2400-0025-00 | In distribution | |
| 6020-0002-02 | In distribution | |
| 6020-0011-00 | In distribution | |
| 4028-0005-00 | In distribution | |
| 6020-0002-01 | In distribution | |
| 6020-0010-00 | In distribution | |
| 6020-0001-02 | In distribution | |
| NOVA 2.19 | In distribution | |
| 2320-0020-00 | In distribution | |
| 4028-0010-00 | In distribution | |
| 6020-0001-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Espion | Diagnosys LLC | 129 |
| Utas | L K C Technologies, Inc. | 34 |
| Stimulator, Photic, Evoked Response | Medtronic Xomed, Inc. | 6 |
| Natus | Xltek | 4 |
| Micromed | Micromed, Inc. | 4 |
| Lifelines Photic Stimulator | Lifelines Ltd. | 2 |
| RETI-port/scan 21 gamma plus | Roland Consult Stasche & Finger GmbH | 2 |
| Sierra Summit | Cadwell Industries, Inc. | 2 |
| RETI-port/scan 21 delta plus | Roland Consult Stasche & Finger GmbH | 2 |
| Stimulator, Photic, Evoked Response | Medtronic Sofamor Danek, Inc. | 2 |
| RETI-port/scan 21 gamma | Roland Consult Stasche & Finger GmbH | 1 |
| Cascade Pro | Cadwell Industries, Inc. | 1 |
Showing 12 of 41. All products under Stimulator, Photic, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101763 | 2011-05-09 |
| K043491 | 2005-03-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-04-02 | Not classified | Software design | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. | 175 units | 2010-04-27 |
| 2004-09-15 | Not classified | Other | The firm established no medical device quality system, no established quality plan and no established quality procedures. | 18 units | 2005-02-15 |
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.