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510(k) K060043

KHAN KINETIC TREATMENT DEVICE (KKT-M1) by Optima Health Solutions International, Inc. — Product Code LXM

K060043 is an FDA 510(k) premarket notification submitted by Optima Health Solutions International, Inc. for the device "KHAN KINETIC TREATMENT DEVICE (KKT-M1)". The FDA issued a decision of Substantially Equivalent on March 23, 2006. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Optima Health Solutions International, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2006
Date Received
January 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Optima Health Solutions International, Inc.

  • K192629 — Spinalytics (December 21, 2019)

Other clearances for product code LXM

  • K234036 — SONIK MONARK 100 (February 15, 2024)
  • K192629 — Spinalytics (December 21, 2019)
  • K172536 — Atlas Percussion Adjusting Instrument (June 20, 2018)
  • K160278 — VSTAAR AdjusteR (November 4, 2016)
  • K130666 — KHAN KINETIC TREATMENT (KKT-M2) (January 23, 2014)
  • K112606 — ACTIVATOR V-E (March 6, 2012)
  • K082218 — MAX ADJUSTING INSTRUMENT (August 13, 2008)
  • K080261 — IMPULSE IQ ADJUSTING INSTRUMENT (April 11, 2008)
  • K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (October 23, 2007)
  • K050428 — TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) (June 14, 2005)

FDA data resources