Home / 510(k) Clearances / K230780

510(k) K230780

MFG-05 by Zimmer Medizinsysteme GmbH — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2023
Date Received
March 22, 2023
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 Zimmer Medizinsysteme GmbH

  • K253408 — CoolTone (January 16, 2026)
  • K251378 — CoolTone (July 14, 2025)
  • K240347 — PTG-05 (July 21, 2024)
  • K240178 — RFG-01 (July 15, 2024)
  • K213256 — ThermoTK (May 25, 2023)
  • K222912 — c1Trac (May 16, 2023)
  • K220601 — CoolTone (April 1, 2022)
  • K220020 — Cryo 7 (February 4, 2022)
  • K203488 — emField (February 19, 2021)
  • K192940 — CoolTone (November 15, 2019)

Other clearances for product code KPI

  • 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)
  • K234061 — StarFormer (July 1, 2024)
  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl (January 18, 2024)
  • K230983 — Unicare (K-UNICARE-USA) (October 20, 2023)