Home / 510(k) Clearances / K161502

510(k) K161502

MC1 Plus by General Project S.R.L. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2016
Date Received
June 1, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by General Project S.R.L.

  • K091615 — MED CONTOUR (May 6, 2010)
  • K062312 — AXIOM PULSED LIGHT SYSTEM (October 16, 2006)
  • K053041 — MED SCULPT (August 2, 2006)
  • K051508 — MED FLASH II INTENSE PULSED LIGHT SYSTEM. (October 5, 2005)
  • K004014 — MD 30 COMPACT (March 16, 2001)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K160075 — Accent XL (August 17, 2016)
  • K142976 — UltraTENS (August 26, 2015)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)