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510(k) K213116

Everyway Incontinence Stimulation System by Everyway Medical Instruments Co.,Ltd — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2021
Date Received
September 27, 2021
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 Everyway Medical Instruments Co.,Ltd

  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K222488 — Everyway Analog OTC TENS (November 15, 2022)
  • K202849 — Everyway Analog OTC TENS, model N103A/N302 (December 22, 2020)
  • K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (November 25, 2020)
  • K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (November 13, 2020)
  • K201335 — Li-Battery powered OTC TENS/EMS Combination Stimulator (October 24, 2020)
  • K192589 — Everyway OTC TENS/EMS Combination (December 19, 2019)
  • K182767 — V2 OTC Pain Relief TENS (October 26, 2018)
  • K182753 — A6 OTC Pain Relief TENS (October 26, 2018)
  • K181707 — Everyway Wireless TENS & EMS Unit (September 26, 2018)

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)