Pelvic Floor Exerciser (PF01)
FDA 510(k) K252748 · Hunan Accurate Bio-Medical Technology Co., Ltd.
510(k) numberK252748
Submission
- Device name
- Pelvic Floor Exerciser (PF01)
- Applicant
- Hunan Accurate Bio-Medical Technology Co., Ltd.
Changsha, CN - Received
- August 29, 2025
- Decision date
- April 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIR – Perineometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1425
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)HIR · Traditional | Pelvital USA, Inc. | 08/01/2024SE |
| K231875 | Vaginal Tactile Ultrasound ImagerHIR · Traditional | Advanced Tactile Imaging, Inc. | 02/22/2024SE |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)HIR · Special | Pelvital USA, Inc. | 12/29/2023SE |
| K231780 | Perifit Care+HIR · Traditional | X6 Innovations | 12/20/2023SE |
| K221476 | PerifitHIR · Traditional | X6 Innovations | 02/10/2023SE |
| K213913 | leva Pelvic Health SystemHIR · Traditional | Renovia, Inc. | 06/30/2022SE |
| K212655 | FlyteHIR · Special | Pelvital USA, Inc. | 09/21/2021SE |
| K212495 | Leva Pelvic Health SystemHIR · Special | Renovia, Inc. | 09/08/2021SE |
| K210764 | FlyteHIR · Special | Pelvital USA, Inc. | 04/13/2021SE |
| K193364 | Intimate Rose Kegel Exercise SystemHIR · Traditional | Plus EV Holdings Dba Intimate Rose | 08/24/2020SE |
More from Plus EV Holdings Dba Intimate Rose
| 510(k) | Device | Decision |
|---|---|---|
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional | 05/14/2026SE |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)DQA · Traditional | 01/02/2025SE |
| K240808 | Pulse Oximeter (WS20A)DQA · Traditional | 10/03/2024SE |
| K171241 | Pulse OximeterDQA · Traditional | 03/27/2018SE |
| K141105 | Pulse OximeterDQA · Traditional | 12/04/2014SE |
Questions and answers
When was Pelvic Floor Exerciser (PF01) cleared by the FDA?
Pelvic Floor Exerciser (PF01) (K252748) received a 510(k) decision of Substantially Equivalent on April 27, 2026, 241 days after the submission was received.
What is the product code of K252748?
The FDA product code is HIR – Perineometer, a Class II (moderate risk) device regulated under 21 CFR 884.1425.