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510(k) K010851

HARRISON HAND HELD ADJUSTING INSTRUMENT by Harrison Cbp Seminars — Product Code LXM

K010851 is an FDA 510(k) premarket notification submitted by Harrison Cbp Seminars for the device "HARRISON HAND HELD ADJUSTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on September 18, 2001. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2001
Date Received
March 21, 2001
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 for product code LXM

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  • 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)
  • K060043 — KHAN KINETIC TREATMENT DEVICE (KKT-M1) (March 23, 2006)

FDA data resources