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510(k) K243112

Curapuls 670 by Enraf-Nonius, B.V. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances by Enraf-Nonius, B.V.

  • K251083 — Compact II (September 12, 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 IMJ

  • K250376 — ViVY (November 5, 2025)
  • K223620 — Reprieve by RegenesisTM (May 24, 2023)
  • K182363 — BTL-703 (January 24, 2019)
  • K173300 — ViaTherm BOOST (May 1, 2018)
  • K162240 — ProMedTek Model C1400 Shortwave Diathermy Device (November 17, 2016)
  • K161862 — ThermoPro (November 14, 2016)
  • K153456 — Megapulse III Shortwave Diathermy (June 14, 2016)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131899 — SW-THERM (March 14, 2014)
  • K121123 — BIOFUSIONARY BEBE (March 10, 2014)