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510(k) K043239

HEALTHSTAR ELITE by Hill Laboratories Co. — Product Code ITH

K043239 is an FDA 510(k) premarket notification submitted by Hill Laboratories Co. for the device "HEALTHSTAR ELITE". The FDA issued a decision of Substantially Equivalent on December 22, 2004. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Hill Laboratories Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2004
Date Received
November 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

Other clearances by Hill Laboratories Co.

  • K090250 — ELECTRO-LIGHT THERAPY (February 11, 2010)
  • K083183 — AKLARUS PHOTOTHERAPY SYSTEM (July 16, 2009)
  • K072256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM W (March 12, 2008)
  • K062256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM (February 26, 2007)
  • K063034 — AIR-FLEX WITH AUTO-DISTRACTION (December 14, 2006)
  • K952357 — THE HILL ADJUSTABLE PODIATRY MODEL (July 6, 1995)
  • K942109 — THE HILL ADJUSTABLE RATH MECHANICAL TABLE (June 22, 1995)
  • K952358 — THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE (June 22, 1995)
  • K942256 — THE HILL ADJUSTABLE EXTEND-R TABLE (June 22, 1995)
  • K952355 — THE HILL ADJUSTABLE 90MD (June 22, 1995)

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