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510(k) K130666

KHAN KINETIC TREATMENT (KKT-M2) by Optima Health Solutions International Corporation — Product Code LXM

K130666 is an FDA 510(k) premarket notification submitted by Optima Health Solutions International Corporation for the device "KHAN KINETIC TREATMENT (KKT-M2)". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2014
Date Received
March 12, 2013
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

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  • K082218 — MAX ADJUSTING INSTRUMENT (August 13, 2008)
  • K080261 — IMPULSE IQ ADJUSTING INSTRUMENT (April 11, 2008)
  • K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (October 23, 2007)
  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (March 23, 2006)
  • K050428 — TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) (June 14, 2005)

FDA data resources