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510(k) K113017

SYS*STIM 240 by Mettler Electronics Corp. — Product Code IPF

K113017 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SYS*STIM 240". The FDA issued a decision of Substantially Equivalent on June 26, 2012. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2012
Date Received
October 11, 2011
Clearance Type
Abbreviated
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 Mettler Electronics Corp.

  • 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)
  • K013192 — SONICATOR PLUS 930, MODEL ME 930 (October 17, 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