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510(k) K072256

HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL by Hill Laboratories Co. — Product Code PFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2008
Date Received
August 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

Other clearances by Hill Laboratories Co.

  • K090250 — ELECTRO-LIGHT THERAPY (February 11, 2010)
  • K083183 — AKLARUS PHOTOTHERAPY SYSTEM (July 16, 2009)
  • K062256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM (February 26, 2007)
  • K063034 — AIR-FLEX WITH AUTO-DISTRACTION (December 14, 2006)
  • K043239 — HEALTHSTAR ELITE (December 22, 2004)
  • K952357 — THE HILL ADJUSTABLE PODIATRY MODEL (July 6, 1995)
  • K942109 — THE HILL ADJUSTABLE RATH MECHANICAL TABLE (June 22, 1995)
  • K952359 — THE HILL ADJUSTABLE HA90C (June 22, 1995)
  • K942256 — THE HILL ADJUSTABLE EXTEND-R TABLE (June 22, 1995)
  • K952356 — THE HILL ADJUSTABLE COUNTERSTRAIN TABLE (June 22, 1995)

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  • K191568 — sam 2.0 Long Duration Ultrasound System (March 6, 2020)
  • K130978 — ZTX ULTRASONIC DIATHERMY DEVICE (November 6, 2013)
  • K081075 — PAINSHIELD MD (August 22, 2008)