Company ยท US
Pelvital USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2024. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HIR | Perineometer | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2024 | K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) Pelvital USA, Inc. | HIR |
| Dec 29, 2023 | K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) Pelvital USA, Inc. | HIR |
| Sep 21, 2021 | K212655 | Flyte Pelvital USA, Inc. | HIR |
| Apr 13, 2021 | K210764 | Flyte Pelvital USA, Inc. | HIR |
| Jul 10, 2020 | K200409 | Pelvital System Pelvital USA, Inc. | HIR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||