Home / 510(k) Clearances / K861837

510(k) K861837

FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND by Fischer Industries, Inc. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
May 13, 1986
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 Fischer Industries, Inc.

  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K940112 — X-RAY FILM PROCESSOR (April 11, 1995)

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)