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510(k) K973506

ACTIVATOR II by Activator Methods, Inc. — Product Code LXM

K973506 is an FDA 510(k) premarket notification submitted by Activator Methods, Inc. for the device "ACTIVATOR II". The FDA issued a decision of Substantially Equivalent on January 27, 1998. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1998
Date Received
September 16, 1997
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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  • 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)
  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (March 23, 2006)

FDA data resources