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510(k) K251083

Compact II by Enraf-Nonius, B.V. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
April 9, 2025
Clearance Type
Traditional
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 Enraf-Nonius, B.V.

  • K243112 — Curapuls 670 (June 25, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)
  • K030297 — FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, (April 28, 2003)

Other clearances for product code IPF

  • 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)
  • K232937 — BTL-899M (December 26, 2023)