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510(k) K082218

MAX ADJUSTING INSTRUMENT by Manna Omni International, Inc. — Product Code LXM

K082218 is an FDA 510(k) premarket notification submitted by Manna Omni International, Inc. for the device "MAX ADJUSTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on Aug 13, 2008. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 13, 2008
Date Received
Aug 6, 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

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  • K130666 — KHAN KINETIC TREATMENT (KKT-M2) (Jan 23, 2014)
  • K112606 — ACTIVATOR V-E (Mar 6, 2012)
  • K080261 — IMPULSE IQ ADJUSTING INSTRUMENT (Apr 11, 2008)
  • K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (Oct 23, 2007)
  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (Mar 23, 2006)
  • K050428 — TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) (Jun 14, 2005)

FDA data resources