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510(k) K030880

VECTORSONIC, MODEL VU-270 by Metron Medical Australia, Pty, Ltd. — Product Code IMG

K030880 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "VECTORSONIC, MODEL VU-270". The FDA issued a decision of Substantially Equivalent on April 18, 2003. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2003
Date Received
March 20, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
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)
  • 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 IMG

  • K244041 — Ultrasound Therapy Workstation (XMS-UET2) (October 7, 2025)
  • K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy Sy (August 26, 2016)
  • K150353 — BTL-4000 (November 13, 2015)
  • K150436 — ComboRehab (November 13, 2015)
  • K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE (November 21, 2012)
  • K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (August 7, 2012)
  • K102524 — FUTURA (November 3, 2011)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K102190 — WINSTIM (March 17, 2011)
  • K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE (January 14, 2010)

FDA data resources