The following data is part of a premarket notification filed by Pelvital Usa, Inc. with the FDA for Pelvital System.
| Device ID | K200409 |
| 510k Number | K200409 |
| Device Name: | Pelvital System |
| Classification | Perineometer |
| Applicant | Pelvital USA, Inc. 1000 LaSalle Avenue, SCH 435 Minneapolis, MN 55403 |
| Contact | Dale Wahlstrom |
| Correspondent | Carrie Hetrick Hetrick Medical Device Consulting LLC 19123 West 60th Lane Golden, CO 80403 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-19 |
| Decision Date | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860331002018 | K200409 | 000 |
| 00860331002001 | K200409 | 000 |
| 00860331002032 | K200409 | 000 |