Home / 510(k) Clearances / K232334

510(k) K232334

DEKA SIMON by El.En S.P.A. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
August 4, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by El.En S.P.A.

  • K260647 — SPECCHIO (April 2, 2026)
  • K251432 — Olo (August 6, 2025)
  • K243683 — Deka Bluebeam (June 12, 2025)
  • K250281 — DEKA LOTUS (February 26, 2025)
  • K241459 — MOTUS PRO Family (June 21, 2024)
  • K233473 — DEKA LOTUS (May 16, 2024)
  • K240752 — DEKA TORO (May 16, 2024)
  • K234057 — NIRVANA (April 10, 2024)
  • K240537 — SMARTXIDE PRO (March 20, 2024)
  • K240497 — Smartxide Tetra Pro (March 12, 2024)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)