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510(k) K021238

FRYE ADJUSTING INSTRUMENT by Frye Health Systems — Product Code LXM

K021238 is an FDA 510(k) premarket notification submitted by Frye Health Systems for the device "FRYE ADJUSTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on October 9, 2002. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
April 18, 2002
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