Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
Pelvital USA, Inc.
PELVITAL USA, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017230582 | 3017230582 | PELVITAL USA, INC. | 1 | N | 2026-01-01 | 860 Blue Gentian Rd Suite 200 Eagan MN US 55121 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 277022 | 1216517932 | K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | HIR | 2024-08-01 |
| 277022 | 2046503786 | K200409 | Pelvital System | HIR | 2020-07-10 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HIR | 2 | 2024-08-01 |
PMN#
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
Pelvital USA, Inc.
Flyte
Pelvital USA, Inc.
Flyte
Pelvital USA, Inc.
Pelvital System
Pelvital USA, Inc.
GUDID#
Flyte System - MTI-1.5
2026-07-06
Flyte - Flyte Gen 1.0 with small wand
2023-06-30
Flyte In-Home Pelvic Floor Treatment - MTI-1
2021-08-04
Flyte In-Home Pelvic Floor Treatment - MTI-1
2021-08-04