The following data is part of a premarket notification filed by Dorsavi Ltd with the FDA for Vimove2.
| Device ID | K163150 |
| 510k Number | K163150 |
| Device Name: | ViMove2 |
| Classification | Electromyograph, Diagnostic |
| Applicant | DORSAVI LTD LEVEL 1, 120 JOLIMONT RD East Melbourne, AU 3002 |
| Contact | Dan Ronchi |
| Correspondent | Bosmat Friedman PUSHMED LLC 1208-12 ROCKFORD RD Toronto, CA L4j 7y9 |
| Product Code | IKN |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KQX |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B7580000PS100000000000 | K163150 | 000 |
| B7580000PS100 | K163150 | 000 |
| B758000VMPLU0 | K163150 | 000 |