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510(k) K896553

MEDX CERVICAL EXTENSION TEST & REHAB MACHINE by Medx Corp. — Product Code IKK

K896553 is an FDA 510(k) premarket notification submitted by Medx Corp. for the device "MEDX CERVICAL EXTENSION TEST & REHAB MACHINE". The FDA issued a decision of Substantially Equivalent on January 2, 1990. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Medx Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1990
Date Received
November 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
Review Panel
PM
Submission Type

Other clearances by Medx Corp.

  • K082581 — C-QUEST (November 14, 2008)
  • K073456 — T-QUEST SYSTEM (December 20, 2007)
  • K041840 — MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (August 20, 2004)
  • K012953 — GIOTTO IMAGE (November 30, 2001)
  • K993893 — MEDX INTECAM INTERFACE (February 10, 2000)
  • K911666 — MEDX MACHINE (July 3, 1991)
  • K895236 — MEDX REHABILITATION MACHINE (September 14, 1989)
  • K884661 — D-SCOPE III (April 12, 1989)
  • K872127 — D-SCOPE II AND D-SCOPE IIC (June 18, 1987)
  • K870703 — SKAN D-SCOPE (February 26, 1987)

Other clearances for product code IKK

  • K123746 — AMES THERAPY DEVICE (May 24, 2013)
  • K952090 — HUMAC SYSTEM (December 11, 1995)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K951916 — CC RIDER, MODEL ME180 (October 4, 1995)
  • K950095 — CYBEX 770 (June 21, 1995)
  • K942229 — MOTIVATOR FTR 2000 (February 27, 1995)
  • K944732 — DEXTER ISOKINETIC (February 3, 1995)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)

FDA data resources