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510(k) K921436

SONICATOR PLUS by Mettler Electronics Corp. — Product Code IMG

K921436 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SONICATOR PLUS". The FDA issued a decision of Substantially Equivalent on April 27, 1993. 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. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1993
Date Received
March 25, 1992
Clearance Type
Traditional
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 Mettler Electronics Corp.

  • K113017 — SYS*STIM 240 (June 26, 2012)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K091540 — MTD 4000 (October 8, 2009)
  • K071137 — SONICATOR PLUS 940, MODEL ME940 (August 1, 2007)
  • K053546 — SONICATOR 740, MODEL ME 740 (May 4, 2006)
  • K043586 — LASER SYS*STIM 540, MODEL ME 540 (May 6, 2005)
  • K042554 — AUTO THERM 390, MODEL ME 390 (October 8, 2004)
  • K031017 — SYS*STIM 208 AND 208A (May 30, 2003)
  • K023083 — SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 (February 28, 2003)
  • K022458 — AUTO*THERM 395, MODEL ME 395 (September 26, 2002)

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)
  • K150436 — ComboRehab (November 13, 2015)
  • K150353 — BTL-4000 (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