Home / 510(k) Clearances / K252601

510(k) K252601

Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) by Hunan Accurate Bio-Medical Technology Co., Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
August 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Hunan Accurate Bio-Medical Technology Co., Ltd.

  • K252748 — Pelvic Floor Exerciser (PF01) (April 27, 2026)
  • K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (January 2, 2025)
  • K240808 — Pulse Oximeter (WS20A) (October 3, 2024)
  • K171241 — Pulse Oximeter (March 27, 2018)
  • K141105 — PULSE OXIMETER (December 4, 2014)

Other clearances for product code KPI

  • K260178 — Pelvic Muscle Trainer (KM510, KM516B) (June 18, 2026)
  • K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (May 6, 2026)
  • K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, (April 28, 2026)
  • K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0- (April 17, 2026)
  • K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P)) (February 12, 2026)
  • K251026 — Regenesis EMS Chair (August 29, 2025)
  • K243079 — NeuroTrac® MyoPlus Pro (MYO120U) (June 26, 2025)
  • K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) (March 27, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241899 — Pelvic Floor Stimulator (Intrelief PFE) (November 27, 2024)