Perifit
The filing describes Perifit as a perineometer for pelvic-floor exercise, with stated use for stress, mild-to-moderate urge and mixed urinary incontinence in women. Its rigid probe has a…
The filing describes Perifit as a perineometer for pelvic-floor exercise, with stated use for stress, mild-to-moderate urge and mixed urinary incontinence in women.
Its rigid probe has a silicone sheath and sensors that measure pelvic-floor contractions. Sensor information is sent wirelessly to a smartphone application for real-time feedback.
Listed Item
Kegel Exerciser with App
Probe and Feedback
The filing says the probe is temporarily inserted into the vagina and describes the product as single-patient and reusable.
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 | X6 Innovations, France |
|---|---|
| FDA product code | HIR |
| Device type | Perineometer |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1425 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K221476 |
| Record published | 2023-05-12 |
| Record revised | 2026-02-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Green Perifit | In distribution | |
| Pink Perifit | 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 |
| 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 |
| InTone® by Viveve | Incontrol Medical, LLC | 1 |
Showing 12 of 36. All products under Perineometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231780 | 2023-12-20 |
| K221476 | 2023-02-10 |
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.