510(k) K252748
K252748 is an FDA 510(k) premarket notification submitted by Hunan Accurate Bio-Medical Technology Co., Ltd. for the device "Pelvic Floor Exerciser (PF01)". The FDA issued a decision of Substantially Equivalent on April 27, 2026. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Hunan Accurate Bio-Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2026
- Date Received
- August 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type