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510(k) K080261

IMPULSE IQ ADJUSTING INSTRUMENT by Neuromechanical Innovations, LLC — Product Code LXM

K080261 is an FDA 510(k) premarket notification submitted by Neuromechanical Innovations, LLC for the device "IMPULSE IQ ADJUSTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on April 11, 2008. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Neuromechanical Innovations, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2008
Date Received
February 1, 2008
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 Neuromechanical Innovations, LLC

  • K023462 — IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTIN (January 13, 2003)

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)
  • 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