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510(k) K962239

SMART ADJUSTER (SA201) by Sigma — Product Code LXM

K962239 is an FDA 510(k) premarket notification submitted by Sigma for the device "SMART ADJUSTER (SA201)". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Sigma has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
June 11, 1996
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 Sigma

  • K926191 — SIGMA 7000 AND SIGMA70002 (August 31, 1993)
  • K851737 — MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & (May 15, 1985)
  • K851738 — MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & (May 15, 1985)
  • K820038 — SIGMA 7000 (January 26, 1983)
  • K830038 — SIGMA 7000-6000 INFUSION PUMPS (January 26, 1983)

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)
  • 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