HIR
- Product code
- HIR
- Device name
- Perineometer
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1425
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 65 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252748 | 2026-04-27 | Hunan Accurate Bio-Medical Technology … | Pelvic Floor Exerciser (PF01) | |
| K240805 | 2024-08-01 | Pelvital USA, Inc. | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | |
| K231875 | 2024-02-22 | Advanced Tactile Imaging, Inc. | Vaginal Tactile Ultrasound Imager | |
| K233362 | 2023-12-29 | Pelvital USA, Inc. | Flyte Mechanotherapy System (aka Flyte System) (MTI-… | |
| K231780 | 2023-12-20 | X6 Innovations | Perifit Care+ |
Official FDA classification page: HIR
Classification and pathway per current FDA publications. Data from openFDA (CC0).