Home / 510(k) Clearances / K031329

510(k) K031329

DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) by Dynatronics Corp. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2003
Date Received
April 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
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)
  • K010948 — DYNATRON STS RX (May 15, 2001)
  • K010565 — DYNATRON STS (May 15, 2001)
  • K993919 — DYNATRON 900 (January 3, 2000)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K160075 — Accent XL (August 17, 2016)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)