Home / 510(k) Clearances / K131926

510(k) K131926

THERMOPULSE by Ibramed Equipamentos Medicos — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2014
Date Received
June 26, 2013
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 Ibramed Equipamentos Medicos

  • K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0 (May 11, 2021)
  • K131917 — NEURODYN COMPACT, NEURODYN II (April 29, 2014)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)
  • K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT (November 26, 2013)
  • K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR (December 19, 2012)

Other clearances for product code IMJ

  • K250376 — ViVY (November 5, 2025)
  • K243112 — Curapuls 670 (June 25, 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)
  • K131899 — SW-THERM (March 14, 2014)
  • K121123 — BIOFUSIONARY BEBE (March 10, 2014)