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510(k) K091540

MTD 4000 by Mettler Electronics Corp. — Product Code ITH

K091540 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "MTD 4000". The FDA issued a decision of Substantially Equivalent on October 8, 2009. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2009
Date Received
May 26, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
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)
  • 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 ITH

  • K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) (July 18, 2025)
  • K243366 — DRX9000C-SL Cervical Spinal Decompression System (June 18, 2025)
  • K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (February 22, 2024)
  • K222912 — c1Trac (May 16, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)
  • K150695 — Modpod (August 13, 2015)
  • K131983 — ITRAC CERVICAL TRACTION SYSTEM (September 10, 2014)
  • K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0 (February 6, 2014)
  • K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (February 1, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)

FDA data resources