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510(k) K993821

VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT by Metron Medical Australia, Pty, Ltd. — Product Code IPF

K993821 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on December 9, 1999. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1999
Date Received
November 12, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
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)
  • K011955 — MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 (July 16, 2001)
  • K001897 — MULTI-STIM, MODEL MS-100 (June 12, 2001)

Other clearances for product code IPF

  • K253542 — Apollo Quattro (APQ-10M) (June 8, 2026)
  • K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) (June 2, 2026)
  • K260142 — StimelMD (SSMD) system (May 27, 2026)
  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)

FDA data resources