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510(k) K011955

MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 by Metron Medical Australia, Pty, Ltd. — Product Code IMI

K011955 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100". The FDA issued a decision of Substantially Equivalent on July 16, 2001. 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
July 16, 2001
Date Received
June 22, 2001
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 Metron Medical Australia, Pty, Ltd.

  • K132137 — MULTISTIM (September 12, 2013)
  • K124010 — ACCUSONIC ADVANTAGE (August 23, 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)
  • 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