Home / 510(k) Clearances / K241516

510(k) K241516

BTL-398 by BTL Industries, Inc. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2025
Date Received
May 29, 2024
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 BTL Industries, Inc.

  • K252561 — BTL-754FF (February 18, 2026)
  • K250309 — BTL-199 (August 7, 2025)
  • K243290 — BTL-785MJ (May 9, 2025)
  • K241270 — BTL-754 (January 30, 2025)
  • K242532 — BTL-785BNF-E (December 13, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K232937 — BTL-899M (December 26, 2023)

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)
  • 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)
  • K230780 — MFG-05 (October 5, 2023)