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510(k) K993919

DYNATRON 900 by Dynatronics Corp. — Product Code ITH

K993919 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON 900". The FDA issued a decision of Substantially Equivalent on January 3, 2000. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2000
Date Received
November 18, 1999
Clearance Type
Traditional
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 Dynatronics Corp.

  • K132057 — DYNATRON PELTIER THERMOSTIM PROBE (January 24, 2014)
  • K113250 — DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE (February 9, 2012)
  • K060814 — DYNATRON ION IONTOPHORESIS ELECTRODE (June 14, 2006)
  • K051680 — DYNATRON DX2 TRACTION UNIT (October 11, 2005)
  • K051261 — DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE (July 25, 2005)
  • K043047 — DYNATRON IBOX IONTOPHORESIS DEVICE (January 7, 2005)
  • K040729 — SOLARIS D890 THERAPY PROBE (June 2, 2004)
  • K031329 — DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL (October 22, 2003)
  • K010948 — DYNATRON STS RX (May 15, 2001)
  • K010565 — DYNATRON STS (May 15, 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