The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a…
The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
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.
Record
Regulatory record for Vaginal Tactile Ultrasound Imager | Listed by | Advanced Tactile Imaging, Inc., United States |
| FDA product code | HIR |
| Device type | Perineometer |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1425 |
| Establishment | Manufacturer |
| 510(k) | K231875 |
| Record published | 2026-04-23 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.