Flyte
The FDA filing identifies the Pelvital System and model MTI-1 as an in-home vaginal device used to condition and strengthen pelvic floor muscles. Its stated intended use is strengthening…
The FDA filing identifies the Pelvital System and model MTI-1 as an in-home vaginal device used to condition and strengthen pelvic floor muscles.
Its stated intended use is strengthening pelvic floor muscles, which the filing says has been found to help women with stress urinary incontinence.
Listed Item
Flyte Gen 1.0 with small wand
Device Components
The device description says MTI-1 is intended to enhance pelvic-floor training during normal Kegel exercises and consists of a vaginal probe and handheld control unit with biofeedback.
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (1), Hunan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Accurate BIO-Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 7 |
| Guangdong Yuxiang Silicone & Plastic Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Pelvital USA, Inc., United States |
|---|---|
| FDA product code | HIR |
| Device type | Perineometer |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1425 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200409 |
| Record published | 2023-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MTI-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pathway | Prometheus Group OF NEW Hampshire Limited, THE | 7 |
| Peritron | Laborie Medical Technologies, Canada ULC | 4 |
| Perifit Care+ | X6 Innovations | 3 |
| Levina | ZMI Electronics Ltd. | 3 |
| Flyte In-Home Pelvic Floor Treatment | Pelvital USA, Inc. | 2 |
| MEP | Personal Medical Corp. | 2 |
| Perifit | X6 Innovations | 2 |
| IVS-2 | Personal Medical Corp. | 2 |
| FemiScan | Bittium Biosignals Ltd. | 2 |
| SenseRx — Anal/Small Vaginal and Vaginal EMG | Personal Medical Corp. | 2 |
| Intimate Rose | Plus EV Holdings Inc | 1 |
| InTone® Nasp | Incontrol Medical, LLC | 1 |
Showing 12 of 36. All products under Perineometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240805 | 2024-08-01 |
| K233362 | 2023-12-29 |
| K212655 | 2021-09-21 |
| K210764 | 2021-04-13 |
| K200409 | 2020-07-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.