Home / 510(k) Clearances / K162240

510(k) K162240

ProMedTek Model C1400 Shortwave Diathermy Device by Promedtek, Inc. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
August 9, 2016
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 Promedtek, Inc.

  • K070931 — MODEL PMT850 (May 24, 2007)

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)
  • 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)