The following data is part of a premarket notification filed by Blink Device Corporation with the FDA for Twitchview System.
| Device ID | K172843 |
| 510k Number | K172843 |
| Device Name: | TwitchView System |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | Blink Device Corporation 1530 Westlake Ave N Suite 600 Seattle, WA 98109 |
| Contact | Justin Hulvershorn |
| Correspondent | Justin Hulvershorn Blink Device Corporation 1530 Westlake Ave N Suite 600 Seattle, WA 98109 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-19 |
| Decision Date | 2018-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860298001079 | K172843 | 000 |
| 00860298001086 | K172843 | 000 |
| 00860298001048 | K172843 | 000 |
| 00860298001031 | K172843 | 000 |
| 00860298001093 | K172843 | 000 |