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510(k) K124010

ACCUSONIC ADVANTAGE by Metron Medical Australia, Pty, Ltd. — Product Code IMI

K124010 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "ACCUSONIC ADVANTAGE". The FDA issued a decision of Substantially Equivalent on August 23, 2013. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2013
Date Received
December 27, 2012
Clearance Type
Traditional
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 Metron Medical Australia, Pty, Ltd.

  • K132137 — MULTISTIM (September 12, 2013)
  • K120171 — ACCUSONIC ADVANTAGE (May 4, 2012)
  • K030880 — VECTORSONIC, MODEL VU-270 (April 18, 2003)
  • K030648 — VECTORSURGE 5 MODEL 470 (March 28, 2003)
  • K030878 — ACCOUSONIC, MODEL AS-270 (March 28, 2003)
  • K030410 — ACCOUSONIC PLUS, MODEL AP-170 (February 20, 2003)
  • K020119 — VECTORSONIC, MODEL VU-200 (July 22, 2002)
  • K011955 — MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 (July 16, 2001)
  • K001897 — MULTI-STIM, MODEL MS-100 (June 12, 2001)
  • K002058 — VECTORSURGE 5, MODEL VS-500 (May 29, 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)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)

FDA data resources